Article preview from "The Gray Sheet" - August 25, 2010
CDRH has sent warning letters to two different orthopedic firms in the past month charging that the companies' personalized knee surgery instrumentation systems are being marketed without proper clearance or approval.
FDA Targets Personalized Knee Surgery Systems With Warning Letters
by David Filmore
CDRH has sent warning letters to two different orthopedic firms in the past month charging that the companies' personalized knee surgery instrumentation systems are being marketed without proper clearance or approval.
Johnson & Johnson/DePuy received a letter dated Aug. 19 from the FDA device center suggesting that the company is illegally selling its TruMatch Personalized Solutions system without PMA or 510(k) go-ahead. FDA posted the letter online Aug. 24.
Biomet was the subject of a July 27 FDA letter, posted online Aug. 17, making the same charge for that firm's Signature personalized patient care system.
Both letters resulted from reviews of the companies' websites by CDRH Office of Compliance officials.
The TruMatch and Signature systems are offered to surgeons that use knee replacement devices manufactured by the respective companies.
Surgeries using the systems require an image be taken of a patient's knee to construct a three-dimensional model. The company uses the model to fabricate custom femoral and tibial cutting guides for use during the patient's total knee replacement procedure. Biomet's system employs computed tomography or magnetic resonance imaging, while DePuy's specifically relies on CT.
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