12 New Research and Development Projects Announced by Orthopedic Companies

Here are 12 orthopedic and spine technology research and development projects.
DePuy Orthopaedics recently announced its plan to spend $7 million on research and development equipment for its company by 2014. At the same time, it announced plans to spend $20 million on manufacturing equipment.
Eminent Spine, a Georgetown, Texas-based medical device company, has recently completed and released the results of a study of its King Cobra Anterior Cervical Plate in which none of the 25 patients experience complications.
Israel-based medical device company Expanding Orthopedics has launched a post-market study in Europe to assess its XPED Expanding Pedicle Screw System for spinal fusion. The study will enroll up to 50 patients and test the usability of the products for 24 months postoperatively.

Stryker Biotech reps get off clean in off-label marketing suit

Federal prosecutors drop all charges against the 2 remaining Stryker Biotech sales reps after the company pleaded guilty to charges of off-label marketing and agreed to pay a $15 million fine.

Federal prosecutors dropped all charges against the 2 remaining Stryker Biotech sales managers charged with illegal off-label promotion and of lying to the FDA.

FDA issues guidance on IDEs for knee cartilage repair/replacement devices and drugs

The FDA issues new guidance on proper submissions for investigational device exemption and investigational new drug applications for products intended to repair or replace knee cartilage.


The FDA this week issued new guidance on getting clearance for clinical trials of products intended to repair or replace knee cartilage.

The guidance covers devices, biologics and hybrid products, outlining required items to include in submission documents for investigation device exemption or investigation new drug applications.

Tennessee Hip Replacement Patient Files Suit Against DePuy For Alleged Debilitating Injuries

Kathryn E. Barnett of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Paul McCurley of Chattanooga, Tennessee, has filed a lawsuit against DePuy Orthopaedics, Inc., and its parent company, Johnson & Johnson, Inc., for the injuries he suffered after his DePuy Pinnacle metal on metal hip implant failed.

The lawsuit charges that DePuy knew that the Pinnacle metal on metal hip generated unusual and dangerous levels of metal debris accumulation in many patients and presented abnormally high risks of early failure. Despite notice of these alleged problems and defects, DePuy continued to promote and sell the Pinnacle metal on metal hip, and has not recalled the product.

On January 17, 2006, McCurley underwent a right total hip replacement procedure usi

Normal shoulder arthroscopic exam

DePuy suspends distribution of custom devices following FDA warning

Posted on : 23 January 2012

Johnson & Johnson subsidiary Depuy Orthopaedics has decided to stop selling all custom devices following an FDA letter warning. The FDA requires DePuy to file new new PMA or 510(k) applications for several components including:

1. PFC Sigma Knee System with titanium components and Global Advantage Shoulder System with titanium heads;

2. PFC Sigma Knee System components, sizes 2.5, 7, and 8;

3. PFC Sigma Knee System, 30 mm – 40 mm thick inserts;

Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery

Medtronic, Inc. (NYSE:MDT) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Aquamantys® SBS 5.0 Sheathed Bipolar Sealer, a new addition to the spine portfolio of the company’s Advanced Energy business.

“We are excited to offer surgeons this new addition to our ever-growing spine portfolio of advanced energy products”

Аптечный рынок Казахстана: итоги первых 9 месяцев 2011

Согласно данным Розничного Аудита ГЛС в Казахстане™, по итогам трех кварталов 2011г. розничный аптечный рынок страны в натуральном вы-ражении сократился на 4% и составил 331,581 млн. упаковок. В денеж-ном выражении (без учета ДЛО) рынок страны продемонстрировал пози-тивную динамику: 2% в казахских тенге и 3% - в долларах. В оптовых ценах рынок достиг 572,366 млн. долл. (83,690 млрд. тенге), в розничных – 699,243 млн. долл. (102,242 млрд. тенге) (рис.1). Средняя стоимость упаковки в розничных ценах составила 2,11 долл., тогда как годом ранее - 1,97 долл. По итогам девяти месяцев 2011г. уровень потребления ГЛС на душу населения составил 42,53 долл. (в 2010г. – 41,94 долл.).

New Score Can Tell Surgeons How They Preform on The da Vinci(R) Robot

Jan. 22, 2012 -- A new assessment system has been developed by a team of researchers to more reliably predict whether surgeons are ready to operate on patients using the da Vinci robot. The new technology, called MScore, provides more precise analysis of actual surgical performance, which has been shown to be difficult to accomplish using common training approaches.

Prior to the introduction of da Vinci simulation training, the only option for most robotic surgeons was to learn on patients, animals and simple plastic models. Such training methods rely on a subjective assessment from proctors rather than precise measurement of movement and actions.

J&J's Depuy to stop selling all custom devices in response to FDA warning

Johnson & Johnson subsidiary Depuy Orthopaedics decides to stop selling all custom devices following an FDA letter warning the company to file new PMA and 510(k) applications for several components.