Strategic Orthopaedic-related 510(k) Update

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk.

Arrowhead Medical Device Technologies
Arrow-Lok Digital Fusion System, K112675*
Stainless steel, 3-dimensional arrow shape for fixation of osteotomies, arthrodeses and reconstruction in lesser toes

Biomet
Comprehensive Reverse Shoulder - El Humeral Bearings, K113121
Comprehensive Reverse Shoulder Humeral Tray, K113069
Indicated for-primary, fracture or revision total shoulder replacement; modifications to original K080642

BioStructures
Interface Bone Void Filler, K112857
For use in the posterolateral spine when mixed with autograft
Builds upon a previous clearance for use in the extremities and pelvis
 

World's First Biodegradable Joint Implant

Finland's Tampere University of Technology (TUT) reports that it has developed a biodegradable joint implant, which it believes to be a world first. Used to treat osteoarthritis and rheumatoid arthritis, the RegJoint recently received the CE mark.

The joint implant was developed in the mid-1990s in a collaborative effort involving TUT's Department of Biomedical Engineering, Conmed Linvatec Biomaterials, Scaffdex Ltd and a group of orthopaedic surgeons, among others, from Tampere University Hospital. Scaffdex will bring RegJoint to market.
 

15-year Comparison of Cementless Total Hip Arthroplasty With Anatomical or High Cup Placement for Crowe I to III Hip Dysplasia

Abstract

This study compared radiological and clinical results of Mallory-Head (Biomet, Warsaw, Indiana) cementless total hip arthroplasty (THA) by anatomical (AP group) or high cup placement (HP group) for Crowe I to III developmental dysplasia of the hip. Of the 68 hips studied, 43 hips were available for 15.3-year follow-up. Ten cups were placed at anatomical center with bulk bone grafting, and 33 cups were at high hip center without bulk bone grafting. No acetabular or femoral components showed loosening in either group. One standard polyethylene liner in a highly placed cup was revised due to excessive wear after 11 years. The average rate of polyethylene wear was 0.128 mm/year in the AP group and 0.148 mm/year in the HP group (except for the revision case). The extent of grafted bone coverage was 34.6% in the AP group. Hip center height was 24.5 mm from the inter-teardrop line in the HP group. The center of the hip horizontal location in the AP group (24.5 mm) and HP group (26.4 mm) was significantly shorter than in normal hips (35.6 mm). Postoperative center-edge angle was 11° (except grafted bone) in the AP group and 25° in the HP group. Mean Harris Hip Score in the AP group improved from 38 points preoperatively to 82 points postoperatively and in the HP group improved from 40 points preoperatively to 88 points postoperatively. Survivorship was 100% in the AP group and 97% in the HP group. Our results indicate that moderate high cup placement without bulk bone grafting at a horizontal locus more medial than that of a normal hip is an alternative durable solution.
 

Clavicle Nonunion in a 10-year-old Boy

Abstract

Posttraumatic clavicle nonunion is rare, particularly in children. Four cases of clavicle fracture nonunion in patients aged 10 years and younger have been reported. A variety of techniques have been used to treat pediatric clavicle nonunions. A 10-year-old boy presented to our institution after a fall, sustaining a right closed midshaft clavicle fracture. No other injuries occurred, and neurovascular examination of the right upper extremity was normal. The fracture was initially treated with a sling for >4 months, and the fracture progressed to a hypertrophic nonunion. Serial radiographs failed to demonstrate progression to union. The patient continued to have pain with activity 4 months after his injury. Clavicle pseudarthrosis was considered; however, radiographs did not have the characteristic appearance of this condition. This fracture nonunion was treated with internal fixation and united with no complication. The patient was back to full activities of daily living 6 months postoperatively. He reported no tenderness at the fracture site or along the hardware. The treating surgeon (A.M.S.) prefers to remove hardware in young children, but the family declined removal. Pediatric posttraumatic nonunion of the clavicle is rare but can be safely treated with plate fixation, with excellent results.
 

Dash™ — Computer Assisted Joint Replacement with the iPod touch (Brainlab)

Biomet releases surgical guide system for partial knee replacement

 Biomet Orthopedics announced the launch of the Signature Personalized Patient Care System for use with the Oxford Partial Knee System. The system enables surgeons to preoperatively plan a knee replacement surgery and precisely place implants by using Signature custom positioning guides, according to a company press release.

 Biomet’s Oxford Partial Knee System is designed to help surgeons preserve and restore normal knee function and movement by replacing only the medial, diseased compartment of the knee. During this process, surgeons use the Signature system to create custom femoral and tibial surgical positioning guides that help achieve optimal joint implant positioning.

“With Signature and the Oxford Partial Knee, surgeons now have state-of-the-art technology for patients undergoing partial knee replacement surgery,” Michael Berend, MD, from Center for Hip & Knee Surgery at St. Francis Health Hospital, stated in the release.

DePuy Receives PMA for TRUMATCH

What with their focus on precision, the engineers at DePuy Orthopaedics, Inc. must be especially thrilled…the company’s TRUMATCH Personalized Solutions with DePuy’s SIGMA RP Knee System has received Premarket (PMA) Supplement Approval from the FDA. Already in use in 17 countries, TRUMATCH Solutions for use with DePuy’s SIGMA Fixed Bearing Knee System was previously cleared in August 2011. And this made DePuy the only orthopedic company to have personalized instrumentation for use with both rotating platform and fixed bearing knees.

“We’re very excited about the opportunity to offer patients the world’s leading mobile bearing knee system, the SIGMA RP Knee, with TRUMATCH Personalized Solutions,” said Andrew Ekdahl, President, DePuy Orthopaedics, in the February 15, 2012 news release. “This approval means patients can now benefit from precise implant positioning, enabled by TRUMATCH Solutions, and the proven performance of both the SIGMA RP and Fixed Bearing Knee Systems, while increasing efficiency in the operating room.”

As indicated by the company, the TRUMATCH is the first system to utilize CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient. Also, TRUMATCH Solutions uses CT scans, rather than MRIs, for improved bone imaging, less scanning time and lower costs. DePuy states that procedures done with TRUMATCH Solutions also require less instrumentation and eliminate up to nine surgical steps compared to total knee replacement performed without TRUMATCH Solutions.

Surgeons call for end to metal hip replacements

Expert surgeons in the UK say patients should no longer be given all-metal hip replacements, despite assurances from regulators amid safety concerns.

Large head metal-on-metal implants can cause serious side effects with wear.

The BBC's Newsnight and the British Medical Journal recently discovered the problems were known about for decades.

The Medicines and Healthcare products Regulatory Agency (MHRA) insists the implants can still be used but the British Hip Society disagrees.
 

Laser-Sintering for Orthopedics

Geometry in the OR…EOS is thrilled that it had a chance to showcase its EOSINT M 280 direct metal laser-sintering (DMLS) system at the recent American Academy of Orthpaedic Surgeons (AAOS) annual meeting. According to the company, there is no shortage of orthopedic applications for this technology.

“An entire new world of orthopedic treatment and procedures has opened up,” said Martin Bullemer, EOS manager for medical business development, in the February 3, 2012 news release. “Because our laser-sintering systems can cost-effectively manufacture any imaginable geometry, and any variation on it, they are changing the way we think about medical products.”

Bicondylar Knee Implant System Incorporates PEEK-Optima CFR Polymer to Prevent Dislocation

A biocompatible polymer from Invibio is utilised as a bearing material for the axle bearings in a rotational knee system from Aesculap. The material is used to provide wear and cold flow resistance and dimensional stability.

Developed to combat the predominant causes of knee implant failure, luxation, wear and malpositioning associated with metal components, Aesculap's EnduRo knee revision system relies on PEEK-Optima carbon fiber-reinforced (CFR) polymer to increase the implant service life and reduce the necessity of subsequent revision surgery. Through use of PEEK-Optima CFR polymer, the service life of the EnduRo knee implant system’s rotational hinge mechanisms matches that of established primary condylar implants, according to the company.

The EnduRo knee implant from Aesculap


"Aesculap and Invibio have benefited from a long, mutually beneficial relationship based on sharing expertise and knowledge. It was through technical expertise, an understanding of our requirements and a long history of proven biocompatibility and implantation success that Invibio was able to provide us with an exceptional solution," says Dipl.-Ing. (FH) Ulf Grimm, Aesculap Product Manager for Knee Endoprostheses. "Throughout this process Invibio has provided valuable processing support and a manufacturing network with the flexibility and scope to meet our device and time targets,” Grimm adds. “Working with Invibio provided us with both a material and processing solution package that enabled our accelerated time to market requirement.”

The EnduRo knee implant is used in the treatment of severe bone defects and insufficiency of the ligamented apparatus. It has been commercially available in Europe since January 2010 and received US FDA 510(k) clearance in December 2010.

Rensselaer Researchers Develop Postsurgery Orthopedic Implant Sensor

An implantable sensor developed by researchers at Rensselaer Polytechnic Institute (Troy, NY) can transmit data wirelessly from the site of a recent orthopedic surgery. Developed by Eric Ledet, an assistant professor in the department of biomedical engineering, the sensor can provide surgeons with detailed, real-time information from the actual surgery site, an in vivo process that could lead to more accurate assessments of a patient’s recovery or provide information about potential complications.

Measuring only 4 mm in diameter x 500 µm in thickness, the sensor does not require a battery, external power source, or electronics in the body. Instead, it is powered by the external device that is also used to capture sensor data. “Our new sensor will give surgeons the opportunity to make personalized, highly detailed, and very objective diagnoses for individual patients,” Ledet remarks. “The simplicity of the sensor is its greatest strength. The sensor is inexpensive to produce, requires no external power source, yet it is robust and durable. We are very excited about the potential of this new technology.” Having a stream of real-time in vivo data should take some of the approximation and subjectivity out of declaring a patient recovered and ready to return to work, Ledet adds.

Capable of being attached to commonly used orthopedic musculoskeletal implants such as rods, plates, and prostheses, the sensor looks like small coils of wire. Once it is implanted, it can monitor and transmit data about the load, strain, pressure, or temperature of the surgery site. In addition, it is scalable, tunable, and easy to configure, enabling it to be incorporated into many different types of implantable orthopedic devices.

Report: Hundreds of thousands exposed to toxic compounds from metal-on-metal hip implants

Hundreds of thousands of patients may have been exposed to toxic chromium and cobalt particles as their metal-on-metal hip implants wear, according to a joint investigation by the British Medical Journal and BBC Newsnight.


Hundreds of thousands of patients may have been exposed to toxic compounds from metal-on-metal implants, according to an investigation by the British Medical Journal and BBC Newsnight, putting them at risk of developing cancer, cardiomyopathy, muscle and bone destruction and changes to their DNA.

The implants, including Johnson & Johnson's (NYSE:JNJ) DePuy ASR and Pinnacle, Smith & Nephew's (NYSE:SNN) Birmingham and Zimmer's (NYSE:ZMH) Durom, release particles of their chromium-cobalt alloy as the metal parts wear against each other, causing tissue and bone death and possibly exposing patients to the risk of developing cancer or even altering their DNA.

"Despite the fact that these risks have been known and well-documented for decades, patients have been kept in the dark about their participation in what has effectively been a large, uncontrolled experiment," according to the report.

Hydroxyapatite Biomaterials Explore New Applications in Coatings and Bone Cements

A new range of hydroxyapatite (HA) biomaterials have potential new uses in antimicrobial and osteopromotive coatings. They could also be used in the development of bone cements with altered structural features that include toughness, solubility, and porosity. Developed by Ceram, the materials have different biological properties. The company changed the basic chemistry of the material, while keeping its physical structure, by putting different elements into HA.
Ceram has filed a patent on the material and is looking for manufacturing partners. It is also open to forming agreements with research institutions to find new applications for the material.

Offset Reamer Driver

Symmetry Medical Inc. has announced that it has launched the Offset Reamer Driver through its OEM Solutions team. Symmetry’s new Offset Reamer Driver is used in minimally invasive surgical techniques, such as the direct anterior approach, to introduce acetabular reamers to the hip joint. The driver features a drive shaft designed and tested to meet the demands of Total Hip Athroplasty (THA) surgery. The product highlights include:
• Acetabulum access is improved due to the low-profile reamer/driver interface connection
• Features an ergonomic silicone overmolded handle
• Compatible with all of Symmetry’s flagship acetabular reamers and together with the Split-Thread Cup Impactor launched last year further expands the Company’s minimally invasive line of hip arthroplasty instruments

For more information, visit www.symmetrymedical.com.

Alexander Orthopaedic Associates Chooses White Plume Technologies to Fill the EMR Gap

Alexander Orthopaedic Associates (AOA) in Largo, FL, has chosen to fill the EMR Gap in their practice with White Plume Technologies between Exscribe electronic health record (EHR) and Advanced Data Systems' (ADSC) practice management system (PM system).

EMRs can be powerful clinical tools but often leave gaps in the billing process unfilled. White Plume Technologies bridges EMR gaps by specializing in accelerating the physician charge capture and medical coding process.

Dr. Allan Alexander of Alexander Orthopedic Associates, an EMR user since 2002 and White Plume client since 2005, explains how White Plume fills the EMR gap:

DePuy receives FDA premarket supplemental approval for TRUMATCH system

DePuy Orthopaedics Inc. has received premarket supplement approval from the FDA for use of TRUMATCH Personalized Solutions with DePuy’s SIGMA RP Knee System. The system was previously cleared in Aug. 2011 for the SIGMA Fixed-Bearing Knee System, making DePuy the only orthopedic company to offer personalized instrumentation for use with both rotating platform and fixed bearing knee prostheses, according to a company release.

“We’re very excited about the opportunity to offer patients the world’s leading mobile bearing knee system, the SIGMA RP Knee, with TRUMATCH Personalized Solutions,” Andrew Ekdahl, president of DePuy Orthopaedics, stated in the release. “This approval means patients can now benefit from precise implant positioning, enabled by TRUMATCH Solutions, and the proven performance of both the SIGMA RP and Fixed Bearing Knee Systems, while increasing efficiency in the operating room,” he stated.

TRUMATCH Personalized Solutions, according to the release, is a surgical instrumentation and computer software system designed to aid both knee implant positioning and procedure efficiency.

Report Slams Response to Metal Hip Troubles

By John Gever, Senior Editor, MedPage Today

Published: February 28, 2012


Regulators on both sides of the Atlantic were slow to inform patients and their doctors about problems with metal-on-metal hip implants and relied on industry officials and consultants in crafting their responses, the BMJ charged.

According to a report appearing online in BMJ, regulators in the U.K., the U.S., and elsewhere should have prevented "a whole class of failing hip implant [sic] from being used in hundreds of thousands of people globally."

The report is based on an investigation commissioned by the journal and the BBC's Newsnight program.

BMJ investigations editor Deborah Cohen reported that the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) first became aware of problems with metal-on-metal implants in 2006, but it was not until 2010 that the agency issued a formal warning to physicians and the public. Complications included high failure rates and possible systemic effects from elevated metal ion levels in the blood.
 

Sandvik Medical Solutions Acquired by Orchid Orthopedic Solutions

Sandvik (Sandviken, Sweden) has reached an agreement with Orchid Orthopedic Solutions (Holt, MI, USA) to divest Sandvik Medical Solutions, a unit within the Sandvik Venture business area with contract manufacturing of medical implants and instruments for orthopaedic and dental applications. “The divestment of Sandvik Medical Solutions is in line with our strategy to exit operations outside of the defined core businesses. There is a strong industrial logic in combining Orchid and Sandvik Medical Solutions,” said Anders Thelin, president of Sandvik Venture.

“The combination of Orchid and Sandvik Medical Solutions will have a unique offering to its customers and become the leading orthopaedic implant supplier globally. The acquisition also demonstrates Orchid’s commitment to be a leader in a consolidating industry,” said Claes Ekstrom, Board Member in Orchid and Partner at Altor Equity Partners.

The divestment is expected to be concluded in March 2012.

Osseon® Announces International Distribution Agreement with Aesculap

Osseon® Therapeutics, Inc. announced today that the company has entered into an International Distribution Agreement with Aesculap AG to distribute its vertebral compression fracture (VCF) treatment devices, including its new CE-Mark approved device – Osseoflex® SB (steerable balloon) in select regions of Europe and Asia. Aesculap is a division of B. Braun Melsungen, a large medical and pharmaceutical company headquartered in Tuttlingen, Germany. The Osseoflex® SB and the other Osseon CE Mark approved VCF medical devices offer a complete platform for treatment of spinal fractures.

"Aesculap is a major medical device company known throughout the world as a quality manufacturer and distributor of surgical instruments. Our new Osseoflex SB (steerable balloon) represents the most precise and controllable treatment device for vertebral compression fracture augmentation currently available to surgeons. Osseon is very excited to partner with Aesculap to distribute our game-changing Osseoplasty® devices and procedures for VCF treatment to patients throughout Europe and the international community and provide state-of-the-art alternatives to the cumbersome devices and procedures currently used to treat fractures of the thoracic and lumbar spine," said John Stalcup, Ph.D., Osseon's CEO.

Blue Belt Technologies Receives CE Mark for Navio PFS System

Blue Belt Technologies, Inc., a medical device company focused on developing the next generation of "smart" surgical instruments providing precise robotic control for use initially in orthopedic procedures and then for other surgical specialties including neurosurgery, spinal and otolaryngology ("ENT"), announced today that it has received CE Mark for the Navio™ PFS System.

The Company's initial market application in Europe is for Unicondylar Knee Replacement ("UKR") which is commonly known as partial knee replacement. A partial knee replacement is surgery to replace either the inside (medial) or outside (lateral) compartment of the knee with an implant. Partial knee replacements are bone-sparing and have been shown to provide better surgical outcomes for patients with cartilage damage contained to a single compartment when compared to total joint replacement. The majority of partial knee replacement surgeries are currently performed using instruments which can be inconsistent and lead to high revision and retreatment rates.

Technique, patient and implant selection key to avoiding fracture during THA

At the Current Concepts in Joint Replacement 2011 Winter Meeting, Craig J. Della Valle, MD, provided tips on the prevention of intraoperative fractures during total hip arthroplasty.

“Prevention is key,” Della Valle said, noting that appropriate exposure is crucial.

In a study of more than 5,000 hip replacements performed by 11 surgeons during a 10-year period, Della Valle and colleagues found that risk factors for fracture include elderly patients, female patients and type of stem used. He noted that flat-wedge taper designs have a high risk for early postoperative and intraoperative fracture. Developmental dysplasia of the hip was also substantial risk factor.

The decision to use a cemented or uncemented implant is also key.

Hip resurfacing: The metal-on-metal bearing material is not the problem

The success of total hip replacement (THR) in the 20th century has been tremendous with improvements in the durability of new designs, bearing materials and fixation techniques. However, the young and active patients have historically had high revision rates compared with older, more sedentary patients, notably when the etiology of the disease is osteonecrosis. Despite great improvements in cementless stem fixation, hip resurfacing arthroplasty (HRA) has the advantages of replicating leg length and offset, and maintaining proximal bone unlike THR. Moreover, dislocation in THR remains a problem when small femoral heads are used. Resurfacing patients also do not report thigh pain as it sometimes happens after THR.

When it comes time for revision surgery, as should be expected for most young and active patients, whether treated with a resurfacing or a primary THR, the preserved bone stock with hip resurfacing provides more favorable conditions for a successful surgery and the technical difficulty of the conversion is comparable to that of a primary THR. This enables patients seeking to restore their previous lifestyle to be more active than with a THR, and numerous authors have reported high levels of physical activity in patients after hip resurfacing.

Ceramic femoral heads generated less linear polyethylene cup wear over 20 years

German researchers concluded after two decades of investigation that ceramic femoral heads create less linear polyethylene cup wear over time compared with metal heads.

While the cobalt-chromium-molybdenum (CoCrMo) group showed a mean 0.190 mm/year wear rate in the long-term study – which examined long-term wear analysis of femoral heads over a 20-year period – the ceramic head group had a 0.107 mm/year wear rate, which caused “significantly less osteolysis and revisions of either component,” the authors wrote in the abstract. The paper was published in Seminars in Arthroscopy.

In 80 patients, surgeons performed 93 consecutive uncemented hip arthroplasties using a titanium-coated cup and cementless stem. Eighty ceramic and 13 CoCrMo 32-mm diameter femoral heads were used. On average, patients followed up for 19.3 years and no patient was lost during follow-up, according to the abstract.

At AAOS 2012: Biomet Debuts Personalized Approach for Partial Knee Replacements

At AAOS in San Francisco, Biomet Orthopedics launched its Signature personalized patient care system designed for use with its Oxford partial knee system. The Signature custom positioning guides enable orthopedic surgeons to create custom femoral and tibial surgical positioning guides to facilitate precise joint implant positioning.

The Oxford partial knee procedure is designed to enable roughly 75% less bone and cartilage to be removed than total knee replacements. The patient-specific positioning guides are created using MRI data.

—Brian Buntz

Melting down hips and knees: The afterlife of implants

As people live longer and medical technology improves, more and more of us will have a surgical implant before we die. We are also getting cremated in larger numbers - and so there is often some expensive metal left among the ashes. Where does it go?

"You tell people what you do, and they think... well, that's a bit strange," says Ruud Verberne above the din of giant sorting machines twirling and clanking.

Verberne is co-founder of OrthoMetals, which recycles metal implants from cremated human bodies. That's everything from steel pins to titanium hips and cobalt-chrome knees.

These are the knees that we have to recover," he says. "Some metals can be sorted by magnets. And the remaining have to be sorted by hand."

Zimmer introduces Chondrofix Osteochondral Allograft

Zimmer Holdings Inc. released its Chondrofix Osteochondral Allograft to repair osteochondral lesions in diarthrodial joints in a single-stage procedure.

“Chondrofix technology offers an innovative new option for early intervention treatment of cartilage lesions through either an open or arthroscopic surgical procedure,” Cheryl R. Blanchard, PhD, senior vice president and chief scientific officer at Zimmer, stated in a company press release.

According to the release, the allograft is designed for patients with osteochondral legions who are considered too young for a total joint replacement or need to reduce the amount of rehabilitation time. It is minimally manipulated using a proprietary process which results in viral inactivation and terminal sterilization. The product also has a 2-year shelf life, and retains the mechanical properties of the pre-processed tissue, including the capacity for immediate load-bearing.

Surgeons Using Metal-Alloy Allergy Tests to Screen Patient Candidates for Total Hip or Knee

Preoperative skin patch testing for metal allergy influenced treatment planning in two-thirds of a small cohort of patients scheduled to receive metal-containing prosthetic devices, a retrospective chart review showed.

All 21 patients with positive tests received allergen-free prostheses and had no complications associated with hypersensitivity.
Post-implantation patch testing led to prosthesis removal in 10 additional patients, and six had resolution of hypersensitivity-associated symptoms.
“The findings of this study support a role for patch testing in patients with a clinical history of metal hypersensitivity before prosthetic device implantation,” Natasha Atanaskova Mesinkovska, MD, PhD, of the Cleveland Clinic, and co-authors wrote in an article published online in Archives of Dermatology.

SI-BONE Awarded Significant "Across Bones" Patent Allowance

SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for broad method claims related to the iFuse Implant System. SI-BONE currently markets the iFuse in the United States and European Union under the iFuse name.

Of considerable significance for SI-BONE, was the breadth of the method claims. These claims include placing an elongated device across a joint from one bone to another, using a guide wire to place the implant, using a device that is rectilinear in cross-section, and a device having an exterior surface to provide bony in-growth. "Because the market for minimally invasive surgical treatment of the SI joint is potentially so significant, this allowance provides SI-BONE with a strong competitive barrier. Additionally, the Company has three dependent claims that further claim square, rectangular, and triangular cross-sections," according to Scott Yerby, Ph.D., Chief Technology Officer, SI-BONE.

Additional Patents For Spinal Implant Technologies Acquired

Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it has acquired two patents related to its current and future surface modification techniques. The first patent protects the company's existing manufacturing process that has been shown to produce superior bone-forming activity when compared to standard PEEK and titanium implant materials during in-vitro cellular studies and has been commercially available in the United States since 2006. The second patent protects Titan Spine's next-generation surface technology that further refines its nano features, which the company expects to produce an even more robust osteogenic response.

AAOS 2012: Novel Lighting Technology Helps Orthopaedic Surgeons See What They Are Doing

Invuity is a rare breed of company. It faces “little to no regulatory barriers,” explains the company’s CEO, Philip Sawyer, at AAOS 2012. “And that enables use to develop multiple products and to react quickly and iterate them.”

Founded seven years ago, its lighting technology was initially developed by an optics expert partnering with an orthopaedic surgeon and researcher. The surgeon was working to develop a less-invasive hip for Zimmer and he realized that lighting problems were holding him back. After about five years, the two men had readied their first product: a sophisticated injection-molded optics device the enables orthopedic surgeons to see into small incisions.

The company has been approached by big orthopaedic companies that report they have spent years in vain trying to develop new lighting technologies similar to the firm’s products. “They come to us and say ‘we quit. We need your help.’” Invuity is now “about three weeks from shipping to one of the biggest spinal players,” explains Sawyer.

The company also markets products for breast surgery (through its own sales force) and for spinal surgery (with its sales force working with distributors). Its products are used in less invasive surgeries, where OR surgeons rely on overhead lights or head lamps and it is very difficult to see as you are operating through smaller and smaller incisions.

It developed a core Eigr technology, which uses injected-molded optics and creates a cool glare and shadow-free light. It is integrated in a clever way with access devices, whether those are retractors or whether it is a coupled to a suction device. And the technology creates a nice pattern of light on the tissue. “It looks more straightforward than it is,” Sawyer says. The technology turns the light and in an optimally efficienty way, transmits it, and it is deflected in a pattern. The light is guided through an advanced polymer and extracted via hundreds of micron-sized parallel structures.

“Each of these [structures] has a unique curve so that there is this redundancy," says Sawyer. That way, if anything enters the stream of light--if it is blocked, there is still a strong pattern of light on the tissue. --Brian Buntz

Smith & Nephew Settles Greek Bribery Charges

Smith & Nephew has agreed to pay the U.S. government more than $22 million to settle charges that the company bribed Greek public doctors over more than a decade.

The government had charged Smith & Nephew's U.S. subsidiary under the Foreign Corrupt Practices Act. The government alleged that the company used a distributor to create a "slush fund" to forward payments to doctors working at government hospitals in Greece in order to win business.

This won't come as a shock to readers of Michael Lewis's book, Boomerang. In the book Lewis claims that Greece has a well known culture of cheating on taxes, bribing public officials and cooking the public books.

The company has committed to pay $22,226,799 in fines and profit disgorgement, maintain an enhanced compliance program, and appoint an independent monitor for at least 18 months to review and report on its compliance program.

Value Pricing Leader IFS Now Marketing Subtalar Implants

Internal Fixation Systems, a Miami, Florida, company founded in 2006, has received 510(k) clearance from the FDA to market its subtalar implants. Made of stainless steel, with a cylindrical shape and tapering on one or both ends, the devices are designed to preserve motion at the ankle joint and deal with arthritis as well as whatever trauma the patient has experienced.

IFS’s CEO, Stephen Dresnick, M.D., says that his firm also currently offers a full line of mini-cannulated screws for small bone fixation as well as a Modular Locking Small Fragment System for treatment of bone fractures and osteotomies.

In describing IFS, Dresnick said that the company takes products that have been around for a long time and made by various companies, such as subtalar implants, and figures out how to make them better. He presents the established designs to his panel of recognized surgeons for analysis and modification and the addition of doctor—recommended enhancements. Dresnick then manufactures and sells the devices for 40% to 60% less than the competition.

“We are a value-priced company,” Dresnick told OTW. “We try to build our products inexpensively. They presently cost too much. Medicare is no longer willing or able to pay separately for implants.” IFS customers include ambulatory surgery centers, hospitals and orthopedic surgeons.

FDA Clears Two New Clavicle Repair Technologies

The FDA has granted 510(k) clearance for two products designed to aid in the repair of the shoulder made by Arnold, Maryland-based Suspension Orthopaedic Solutions, Inc. One product is the Distal Clavicle Fracture Fixation System and the second is the Mid-Shaft Clavicle Plate.

The two devices, made of stainless steel, “can be used in combination for the repair of distal-clavicle fractures,” company CEO Robert S. Collins told OTW. “These two new FDA clearances will expand the availability of our confidence-inspiring solutions for orthopaedic surgeons who treat difficult shoulder injuries, and reflect Suspension’s core mission of bringing meaningful innovation to challenging orthopaedic injuries.”

The Distal Clavicle Fracture Fixation System features Suspension’s patent-pending T-Loc Technology which enables knotless, protected and precisely controlled tension for secure fixation of multiple soft-tissue injuries.

замена сустава коту!!!!

Tabby Cat Gets Knee Replacement

It is not just humans who are getting knee replacements. A ten-year-old tabby cat named Cyrano, in a medical first, received a new knee last week. Veterinary doctors believe this to be the first feline total knee replacement performed in the U.S.

Doctors from Texas and Washington D.C. were present in the operating theater to assist the three orthopedic surgeons from the North Carolina State University College (NCSU) of Veterinary Medicine in the six hour surgery. The implant, designed and fabricated by an international team of collaborators, was made from dense plastic and a cobalt chromium alloy, using a laser process that hardens metal powder to replicate bones.

"The surgery was kind of a bit difficult, but it went very smoothly," said Dr. Denis Marcellin-Little of NCSU, who led the surgical team, in the January 28 news release.

The cat had previously been treated successfully for bone cancer. But the treatment had left the animal with a painfully damaged knee. The cat’s owner, Sandy Lerner of Upperville, Virginia, sought the knee replacement in an effort to avoid having to amputate the cat's rear left leg. In 2005, Marcellin-Little had performed the world's first surgery to fuse leg implants with a cat's bone tissue, so Cyrano's owner turned to him for help.

Marcellin-Little said the 20-pound tabby's big bones were a plus. "He's already able to stand," he said. "His foot is in the right place, and he can put his foot on the ground. So far, so good. Now we have to be very patient with letting his tissues reattach, and it has to heal slowly."

DePuy Announces Several Advancements In Orthopedic Treatment

DePuy Orthopaedics, Inc. (DePuy) announced the launch of several new advancements in orthopaedics spanning joint replacement, shoulder reconstruction and hip revision surgery, each designed to optimize or streamline procedures, personalize care and provide clinical and economic value.

The announcement was made here at the 79th Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

New treatment options include AOX Antioxidant Polyethylene, RECLAIM Modular Revision Hip System, GRIPTION TF Acetabular Augment System, GLOBAL UNITE Platform Shoulder Arthroplasty System and GLOBAL STEPTECH Anchor Peg Glenoid (APG). DePuy is also introducing the latest generation of TRUMATCH Personalized Solutions technology for use with its SIGMA Fixed-Bearing Knee System, one of the most widely used knee systems in the world.

'Our ever expanding portfolio enables us to offer solutions to most of the orthopaedic challenges a surgeon or patient may face,' said Andrew Ekdahl, President, DePuy Orthopaedics. 'Our goal is to provide surgeons and health care institutions with more choices that help fill clinical needs, streamline procedures and personalize treatment. We believe that products that focus on these areas will help enhance care while reducing health care costs.'

Last year, DePuy received several FDA product approvals and clearances, including premarket approval (PMA) for AOX Polyethylene, an antioxidant polyethylene designed for optimal wear resistance and long-term oxidative stability, and the PINNACLE COMPLETE Acetabular Hip System, the industry's first and only ceramic-on-metal hip bearing approved for sale in the United States.

The PINNACLE Cup System, which has more than 10 years of documented clinical success and has been provided for more than one million patients, is the only acetabular cup system on the market with PMA approvals for both ceramic-on-ceramic and ceramic-on-metal bearing options. The PINNACLE Ceramax Ceramic Total Hip System, featuring a new generation of ceramic material, received its PMA approval in 2010. The all ceramic implant is the only device in the U.S. with BIOLOX delta, the fourth generation of BIOLOX ceramic. Its three previous versions have been used in millions of implants throughout the world.[i] The PINNACLE System is now the only acetabular cup system with five bearing options, providing surgeons with a full range of options to meet the clinical needs of their patients.

AAOS 2012 Launches

AOX Polyethylene

Approved for use with the SIGMA Rotating Platform Knee System and LCS COMPLETE Mobile Bearing Knee System, the new AOX Polyethylene delivers an advanced blend of polyethylene resin and a unique antioxidant, COVERNOX, to create a new polyethylene material that is highly efficient in trapping free radicals and scavenging oxygen. By eliminating the annealing or remelting process, AOX Polyethylene delivers oxidative stability and optimum wear resistance without compromising the mechanical properties or strength of the polyethylene.[ii], [iii], [iv] By introducing COVERNOX Antioxidant into the base resin before the polyethylene is consolidated, the process enables the antioxidant to be uniformly dispersed and remain blended, eliminating the risk of outward migration.

Hip Revision Solutions

The RECLAIM Modular Revision Hip System is engineered to deliver a high level of implant strength. This system has been studied extensively through analytic techniques and rigorous laboratory testing and has demonstrated promising capabilities, particularly with respect to construct fatigue strength and torsional stability. The modular design of the RECLAIM Revision Hip System features novel instrument technology that may improve intraoperative handling, flexibility and efficiency. The modularity of the system offers surgeons numerous options to treat a patient's unique pathology while simplifying the instrumentation required in surgery.

DePuy's GRIPTION TF Acetabular Augment System addresses bone defects in moderate to complex acetabular revision surgery using a highly porous structure made from commercially pure titanium; a strong, corrosion-resistant metal that has high surface roughness and a similar elasticity to bone. The GRIPTION TF System offers a wide range of options and configurations for the patient at the time of surgery and is designed to work in conjunction with the full range of PINNACLE Acetabular Cup options.

Procedural Efficiency in Knee Replacement

TRUMATCH Personalized Solutions 2.5i provides enhanced capabilities that aid implant positioning and procedural efficiency. TRUMATCH, which reduces procedure time by up to 35 minutes, [v] is the first system to utilize CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient. The use of CT scans, rather than MRIs, results in improved bone imaging, less scanning time and lower costs. [vi]

Advanced Shoulder Solutions

DePuy is launching two new shoulder solutions. The GLOBAL UNITE Platform System, which treats fractures of the proximal humerus, helps improve tuberosity healing and is the only system that can later be easily converted to a reverse shoulder arthroplasty for treatment of arthritis with a torn rotator cuff. The GLOBAL STEPTECH APG System, has been designed to correct excessive retroversion caused by posterior glenoid bone loss, closely recreate the original glenohumeral joint line, and minimize the removal of healthy bone. The prosthesis incorporates a proprietary step design with an anterior backside surface that is spherical and a posterior backside surface that is conical. This unique dual surface design effectively counteracts posterior loading.

Important Safety Information

The performance of joint reconstruction and replacement products depends on a patient's age, weight, activity level and other factors. There are potential risks, and recovery takes time. People with conditions limiting rehabilitation should not have these surgeries. Patients should consult with an orthopaedic surgeon to determine if joint reconstruction and replacement surgery is appropriate for them.

About DePuy Orthopaedics

DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, trauma and extremities, as well as bone cement and operating room products. It is part of the DePuy Family of Companies, which has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care. These companies are unified under one vision - Never Stop Moving - to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world. Visit www.depuy.com for more information.

i] CeramTec. 'BIOLOX delta - Nanocomposite for Arthroplasty: The Fourth Generation of Ceramics.' p. 4.

[ii] Data on File at DePuy Orthopaedics, Inc. WR070300.

[iii] Data on File at DePuy Orthopaedics, Inc. WR070248.

[iv] Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants. ASTM Designation: F648-00

[v] Data on file at DePuy. Operating room time includes preparation, operating room, and turnover time.

[vi] D. White, K. L. Chelule, B. B. Seedhom. Accuracy of MRI vs CT imaging with particular reference to patient specific templates for total knee replacement surgery. Int J Med Robotics Comput Assist Surg 2008; 4: 224-231.

Stryker Hip Suit Isn't Completely Preempted, 5th Circuit Rules

Federal law regulating medical devices doesn't completely preempt the claims of a plaintiff who alleged that a hip replacement product malfunctioned and caused him injury, the 5th Circuit has ruled.

The plaintiff underwent surgery involving the implantation of a Trident hip replacement system in his left hip. The Trident system is manufactured by Stryker Corp. The plaintiff later experienced loosening in the joint which required a surgical revision of his hip replacement.

The plaintiff filed a product liability suit, alleging that contamination of the shell of the Stryker device during the manufacturing process prevented bonding with his bone.

Stryker argued that the plaintiff's state-law claims were completely preempted by the Medical Device Amendments to the Food, Drug, and Cosmetics Act.

The court agreed that the plaintiff's breach of express warranty claims were completely preempted, as well as his claims for strict liability, design defect and negligence insofar as they were premised on failure to warn or a marketing defect.

However, the court concluded that there was no preemption of the plaintiff's strict liability and negligence claims to the extent they were based on manufacturing defects arising from a violation of Stryker's manufacturing practices or those approved by the U.S. Food and Drug Administration.

The court concluded that those claims were "parallel claims" permitted under Riegel v. Medtronic (552 U.S. 312). (See "State law claims over medical devices are preempted," Lawyers USA, March 10, 2008.)

"We ... hold that if a plaintiff pleads that a manufacturer of a Class III medical device failed to comply with either the specific processes and procedures that were approved by the FDA or the [FDA's Current Good Manufacturing Practices] themselves and that this failure caused the injury, the plaintiff will have pleaded a parallel claim," the court said.

The court similarly concluded that there was no preemption of the plaintiff's claims for breach of implied warranty.

Total Knee Replacement Can Be Deferred Using Biologic and Bionic Meniscus Replacement Procedures, Data Show

At American Academy of Orthopedic Surgeons in San Francisco, a group of renowned orthopedic surgeons from around the world gathered to discuss the latest findings for meniscus transplantations. New data on knee joint cartilage and meniscus transplantation presented at the 27th annual Meniscus Transplantation Study Group revealed that the meniscus tissue can be successfully replaced by tissue replacements such as cadaveric allografts, using artificial materials such as polyurethane scaffolds, and using polycarbonate-urethane implants. These advances bode well for all those who have developed knee pain or arthritis and want to avoid a total knee replacement.

The meniscus cartilage is the key shock absorber in the knee joint, and when injured, it is often removed. Loss of this critical structure often leads to joint pain and arthritis. Of the 1.4 million knee surgeries occurring in the United States each year, 98% of them result in the removal of meniscus tissue.

Eight investigators from five different countries presented on the science of meniscus replacement. From the United States, Kevin R. Stone, MD of the Meniscus Transplant Center at The Stone Clinic in San Francisco presented the largest and longest study of meniscus transplantation. The study spanned 16 years of data with approximately 80% success at improving patient pain and function in both pristine and arthritic knees. Many patients were able to return to a wide range of sporting activities after undergoing meniscus transplantation.

Mathew T. Provencher, MD, MC, USN of the US Navy presented data on the biomechanical changes in the knee for soldiers with a new meniscus and an osteotomy realignment procedure. The soldiers' pain was diminished and some were able to return to active duty.

Peter Verdonk, MD of Belgium unveiled a novel artificial meniscus implant made from polycarbonate-urethane. The implant is meant for patients who have a missing meniscus and knee pain, but whose knees are otherwise healthy. The data is preliminary but represents a new bionic approach to cartilage replacement. Dr. Verdonk also described the successes and failures of an artificial scaffold designed to regrow tissue called Actifit. The complication rate is still too high at 20%, but improvements are planned.

The global nature of cartilage loss and arthritis is being addressed and today offers young and old patient solutions that can be performed without removing bone or opening the joint, and permits return to sports.

SOURCE Meniscus Transplant Center

Smith & Nephew plc Announces Result Of New Study For BIRMINGHAM HIP Resurfacing (BHR) System

Smith & Nephew (NYSE:SNN; LSE:SN), the global medical technology business, today announced the results of a new study for its BIRMINGHAM HIPT Resurfacing (BHR) System. The study, carried out at the request of the FDA, followed the progress of the first 400 BHR patients in the United Kingdom and found that after 10 years, 99% were either satisfied or extremely satisfied with their BHR procedure.

"These results further exemplify why the BHR Hip is unlike any other metal-on-metal implant," says John Soto, Senior Vice President for Smith & Nephew's Global Hip Franchise. "Not only does the BHR Hip offer all the advantages of hip resurfacing, including bone-conservation, greater range of motion and decreased risk of dislocation, but it does so while maintaining implant survivorship rates that are on par with, or in some patient populations even better
than, traditional total hip replacement which has long been considered the most successful orthopaedic surgical procedure for relieving chronic pain."

POLARCUP™ Dual Mobility Hip System From Smith & Nephew Now Available in US

Smith & Nephew (NYSE: SNN; LSE: SN), the global medical technology business, is introducing the clinically proven POLARCUP™ Dual Mobility Hip System to orthopaedic surgeons in the US at this year's American Academy of Orthopaedic Surgeons (AAOS) annual meeting in San Francisco. The system is specifically designed to address the challenges of treating patients – in both primary and revision cases – who are susceptible to dislocation and need enhanced stability.

Backed by 10 years of clinical history in Europe and other markets outside the US, the POLARCUP System allows surgeons to implant a smaller, constrained femoral component within a larger, anatomically sized polyethylene head, thus providing greater stability by increasing range of motion and jump distance. "This stability philosophy is widely used in the European market where surgeons have extensive experience with dual mobility in elderly and less active patients," says John Soto, Senior Vice President for Smith & Nephew's Global Hip Franchise.

Anterolateral Approach for Tibial Pilon Fractures

Abstract

The anterolateral approach to the tibia has been popularized for management of tibial pilon fractures. This approach offers the benefit of improved soft tissue coverage and the potential for a lower rate of wound-healing complications by avoiding incision placement over the subcutaneous border of the tibia. Although the fracture pattern dictates specific plate use, antomically designed anterolateral plates are useful for fixation of common fracture patterns. Additional exposures may be required to address other areas of the fracture, such as the medial malleolus, which cannot be accessed through this approach.

Dr Hak is from the Department of Orthopedic Surgery, Denver Health/University of Colorado, Denver, Colorado.

Dr Hak has no relevant financial relationships to disclose.

Correspondence should be addressed to: David J. Hak, MD, MBA, Department of Orthopedic Surgery, Denver Health/University of Colorado, 777 Bannock St, MC 0188, Denver, CO 80204 (David.Hak@dhha.org).

Locking Plate Fixation for Proximal Humerus Fractures

Abstract

Locking plates are increasingly used to surgically treat proximal humerus fractures. Knowledge of the bone quality of the proximal humerus is important. Studies have shown the medial and dorsal aspects of the proximal humeral head to have the highest bone strength, and this should be exploited by fixation techniques, particularly in elderly patients with osteoporosis. The goals of surgery for proximal humeral fractures should involve minimal soft tissue dissection and achieve anatomic reduction of the head complex with sufficient stability to allow for early shoulder mobilization. This article reviews various treatment options, in particular locking plate fixation.

Locking plate fixation is associated with a high complication rate, such as avascular necrosis (7.9%), screw cutout (11.6%), and revision surgery (13.7%). These complications are frequently due to the varus deformation of the humeral head. Strategic screw placement in the humeral head would minimize the possibility of loss of fracture reduction and potential hardware complications.

Locking plate fixation is a good surgical option for the management of proximal humerus fractures. Complications can be avoided by using better bone stock and by careful screw placement in the humeral head.

Repair of Medial Collateral Ligament Injury During Total Knee Arthoplasty

Abstract

Intraoperative midsubstance lacerations of the medial collateral ligament (MCL) must be addressed during surgery, and failure to obtain coronal plane stability could affect patient outcomes and satisfaction. This article reports our results of a series of patients who sustained an intraoperative MCL injury during a primary total knee arthroplasty and were treated by direct primary repair and no change in implant constraint or postoperative protocol.

Over a 5-year period, 9 patients sustained this complication. We reviewed their subjective satisfaction and stability, as well as objective measures such as functional scores, physical examinations, and radiographs. Average patient age was 58 years, and mean patient body mass index was 43.3. All patients were satisfied with the procedure and demonstrated no instability on physical examination. Average Knee Society pain score was 91.5 and functional score was 73.3. No radiographic changes or signs of loosening were noted. This novel approach for intraoperative midsubstance lacerations of the MCL does not involve altering implants or postoperative protocols and has encouraging results.

First comprehensive look at how metal-on-metal total hip replacements fail in patients

A study by Hospital for Special Surgery researchers has provided the first comprehensive look at just how metal-on-metal total hip replacements are failing in patients around the country. Made possible by what is thought to be the largest archive of failed joint replacements, the research should help doctors develop a better hip replacement for future patients. The study will be reported at the upcoming annual meeting of the American Academy of Orthopaedic Surgeons, Feb. 7-11.

"This paper is the first step in what is a path to try to understand what the problems are with metal-on-metal joints," said Timothy Wright, Ph.D., Kirby Chair of Orthopedic Biomechanics at Hospital for Special Surgery (HSS). He said that information gleaned from the study should be useful in improving metal-polyethylene implants, the most common hip implant put in patients today