Stryker applies for approval of spinal putty

Stryker, the medical equipment manufacturer, has applied for a pre-market approval with the FDA for OP-1 putty for lumbar spine fusion surgery.

OP-1 putty is a recombinant human protein designed to stimulate the formation of new bone material in patients who have had lumbar spine fusion surgery – an operation to combine two or more vertebrae, sometimes used as a cure for chronic back pain.

Currently the putty is only approved for use in 4,000 patients a year under a humanitarian device exemption. OP-1 Implant, a similar product designed for patients who have suffered non-union bone fractures that will not heal on their own.

In additional news, Stryker was named as one orthopaedic equipment company to be subpoenaed by the US Department of Justice over possible violation of antitrust laws. Biomet and De Puy are also involved.

Stryker said the request is not unusual. Last year Zimmer, Biomet, Johnson and Johnson and Stryker acceded to a similar request from the department of justice, according to Reuters.

Michael Matson, an analyst with Wachovia, told the news agency: “It does appear that the Department of Justice has its sights set on the orthopedic industry.”

Stryker said it would cooperate fully with any investigations.

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