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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 28-May-09 BY LAUREN UZDIENSKI, MAY 28, 2009

Regulatory
Blackstone Medical received an FDA warning letter relating to the ICON Modular Spinal Fixation System, which the company voluntarily recalled in December of 2005. The FDA said Blackstone failed to adhere to its own risk management procedures and failed to maintain CAPA procedures to address product, process and quality nonconformities.

Medtronic received FDA approval to market its Bryan cervical disc on May 12. The device, which is titanium and polyurethane, is indicated for use after the patient fails six weeks of conservative therapy.

Small Bone Innovations received FDA approval to market its STAR mobile-bearing ankle. The product is the first of its kind on the U.S. market, and the company will collect data on its safety and effectiveness for the next eight years.

Product Development Update
Kensey Nash released pre-clinical data from two studies on its cartilage repair device (CRD), which the company is developing to repair damaged articular cartilage. The first revealed "superior healing characteristics" for the CRD compared to microfracture at four months. The second study found that defects healed more rapidly with the CRD than in controls and that de novo tissue formed at 12 months was "mechanically sound and durable, and resembles natural articular cartilage." The device was also shown to be able to stay in place without additional fixation.

Legal
Three St. Paul, Minnesota hospitals will pay the U.S. government $2.3 million to settle claims of fraudulent billing for kyphoplasties between 2002 and 2007. In May 2008, Medtronic settled similar allegations for $75.0 million.

Distribution
Premier Purchasing announced new spinal implant agreements with Aesculap, DePuy Spine and Medtronic. Terms of the agreements, which are effective July 1, were not disclosed.

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