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.

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