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.