FDA warns Biomet on knee replacement planning system

August 17, 2010 by MassDevice staff

The Food & Drug Administration warns Biomet that its Signature Personalized Patient Care system, a pre-operative surgical planning offering for knee replacement procedures, isn't cleared for market.

Biomet logo

The Food & Drug Administration warned Biomet Inc. that its personalized knee implant planning offering, the Signature Personalized Patient Care system, lacks approval or clearance to be on the market in the U.S.

In a July 27 warning letter, the FDA warns the Warsaw, Ind.-based firm that the system, which uses MRI and CT scans to develop a pre-operative plan for implanting Biomet's Vanguard knee replacement, does not have pre-market approval, an investigational device exemption or 510(k) clearance from the watchdog agency.

"The Signature Personalized Patient Care system is adulterated ... because you do not have an approved application for premarket approval (PMA) in effect ... or an approved application for an investigational device exemption (IDE)," according to the warning letter. "The device is also misbranded ... because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by sections 510(k)."

Biomet said it replied to the warning letter August 3, "explaining why the company believes that the Signature Personalized Patient Care system, which is manufactured by Materialise NV, has been appropriately marketed under a 510(k) premarket clearance."