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March 14-18 - American Association of Orthopaedic Medicine Annual Meeting 2017

March 14-December 31 - Canaccord Genuity Musculoskeletal Conference

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Orthopedic and Dental Industry News

March 2009

Four of Big Five Settle with DOJ; Compliance Monitors Leave BY DAVID KRESSEL, MARCH 31, 2009

Eighteen months after the Department of Justice entered into Deferred Prosecution Agreements (DPA) with Smith & Nephew, Johnson & Johnson (Depuy), Zimmer and Biomet, and a Non-Prosecution Agreement with Stryker, the DOJ has announced it has dismissed the criminal charges... more

Judge Dismisses Whistleblower Lawsuit Against Medtronic Surgeons BY JOHN MCCORMICK, MARCH 27, 2009

Last Friday, federal judge Richard Stearns dismissed the well-publicized whistleblower lawsuit alleging that certain spine surgeons accepted kickbacks for using Medtronic's spinal implants. He also blocked a motion by the two women to file an amended complaint. The lawsuit accused... more

Musculoskeletal News Roundup 26-Mar-09 BY LAUREN UZDIENSKI, MARCH 26, 2009

Regulatory Bonesupport received the CE mark for Cerament Bone Void Filler, a ceramic bone substitute primarily used for the treatment of osteoporotic fractures. IlluminOss Medical received the CE mark for its Photodynamic Bone Stabilization System. According to the company, the... more

Ozone Injections Could Reduce Back Pain BY LAUREN UZDIENSKI, MARCH 25, 2009

Yes, that ozone. The molecule that filters UV rays in the atmosphere and is a pollutant on the ground could have applications for reducing back pain, according to new studies out of Europe. Over the past five years, it is... more

NYT: Patients Delaying Elective Surgery BY LAUREN UZDIENSKI, MARCH 23, 2009

The New York Times reported last week that hospitals are seeing a slowdown in elective surgery, hip and knee replacements among them, as the recession forces patients to delay procedures on account of financial concerns. These delays could subject patients... more

JBJS Surveys Physicians about Surgical Errors BY LAUREN UZDIENSKI, MARCH 19, 2009

In a survey of 917 members of the AAOS, more than half reported observing surgical errors in the past six months. The study, published in JBJS, highlighted some of most frequent mistakes and described initiatives by the AAOS and others... more

Musculoskeletal News Roundup 19-Mar-09 BY LAUREN UZDIENSKI, MARCH 19, 2009

Earnings TiGenix announced 2008 financial results this week, reporting a widening net loss as the company prepares to launch ChondroCelect in Europe. The company's net loss was EUR 15.2 million ($21.4 million), an increase of 27% over 2007. As the... more

President Obama Nominates FDA Commissioner BY LAUREN UZDIENSKI, MARCH 17, 2009

President Obama announced his nominee for FDA commissioner over the weekend, naming Margaret A. Hamburg as the potential successor to Andrew von Eschenbach as the head of FDA. Joshua Sharfstein, the Baltimore Health Commissioner, will serve as Hamburg's deputy--unlike Hamburg,... more

The FDA Continues to Become More Conservative, Despite ReGen Experience BY DAVID KRESSEL, MARCH 13, 2009

In a recent Wall Street Journal article we blogged about last week, it was alleged that ReGen Biologics was able to put extreme pressure on FDA employees to ensure their Menaflex meniscus repair device was cleared via 510(k). If these... more

Stryker Facing Federal Grand Jury Investigation Over the Marketing of OP-1 BY LAUREN UZDIENSKI, MARCH 12, 2009

As Stryker's long-awaited FDA panel session for OP-1 approaches, the company announced that it's facing a federal grand jury investigation into marketing practices surrounding the device. Specifically, allegations include the illegal promotion of OP-1 products and Calstrux, misbranding of devices... more

Musculoskeletal News Roundup 12-Mar-09 BY LAUREN UZDIENSKI, MARCH 12, 2009

Earnings BioMimetic Therapeutics reported a net loss in 4Q:08 of $12.2 million, or $0.65 per share, widening from a net loss of $6.9 million, or $0.37 per share, in 4Q:07. Analysts had forecast a net loss of $0.53 per share.... more

Biologic Orthopaedic Society Formed to Promote the Use of Orthobiologics BY LAUREN UZDIENSKI, MARCH 9, 2009

At AAOS last month, Allan Mishra, M.D. and Pietro S. Randelli, M.D. co-chaired the inaugural meeting of the Biologic Orthopaedic Society, a new organization designed to further the study and market adoption of biologics worldwide. Prior to BOS's formation, “No... more

ReGen's 510(k) Clearance Under the Microscope at the WSJ BY LAUREN UZDIENSKI, MARCH 5, 2009

When ReGen Biologics received 510(k) clearance last December for its meniscal repair product, Menaflex, it looked like a happy ending for the company after two failed FDA submissions and a long back-and-forth with the agency. Now it appears the story... more

Quality Concerns Color Scans BY LAUREN UZDIENSKI, MARCH 5, 2009

The New York Times has published a series of articles on the shortcomings of imaging, suggesting that what shows up in scan may not help a physician diagnose a patient or determine the most effective treatment plan. Now the newspaper... more

Musculoskeletal News Roundup 5-Mar-09 BY LAUREN UZDIENSKI, MARCH 5, 2009

Earnings Alphatec Spine reported consolidated revenues for 4Q:08 of $28.4 million, an increase of 33% from the $21.3 million reported for 4Q:07. U.S. revenues for 4Q:08 were $22.0 million, an increase of 29% from the $17.1 million reported for 4Q:07.... more

AAOS 2009: Procedure Volumes Steady, Though Economic Worries Loom BY LAUREN UZDIENSKI, MARCH 3, 2009

The orthopedic industry convened in Las Vegas last week for what was a slightly quieter AAOS than we've seen in recent years, shadowed by worries about the economy. More than new products and deals, the tone at this year's conference... more


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