FDA Warns Biomet on Knee Replacement Planning System

The U.S. Food and Drug Administration (FDA) has warned Biomet Inc. that its pre-operative surgical planning system for knee replacement procedures lacks the approval and clearance to be on the U.S. market.

In a July 27 warning letter, the FDA said the Signature Personalized Patient Care system does not have premarket approval, an investigational device exemption or 510(k) clearance. The Signature system uses magnetic resonance imaging and computed tomography scans to develop a pre-operative plan for implementing Biomet’s Vanguard knee replacement.

“The device is misbranded…because you did not notify the agency of your intent to introduce the device into commercial distribution as required by sections 510(k),” the FDA’s warning letter stated.

Warsaw, Ind.-based Biomet replied to the warning letter on Aug. 3, and explained why the company believes the Signature Personalized Patient Care system—manufactured by Belgium-based Materialise NV—has been “appropriately marketed under a 510(k) premarket clearance.”

Materialise won seven 510(k) clearances between 1996 and 2009 for devices ranging from a “CT-modeller system” in April 1997 to its Mimics device and implant design software in 2008. Late last year, the company won a 510(k) nod for Zimmer Holdings Inc.’s Patient Specific Instruments system, which is nearly identical to the Biomet offering. Materialise provides rapid prototyping services to the industrial and medical sectors.

Biomet executives released a statement saying they are “committed to working with the FDA to resolve the issue in the best interests of patients and their doctors without disruption to patient treatment.”