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."
Materialize 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 (NYSE:ZMH) Patient Specific Instruments system, which is nearly identical to the Biomet offering.
"We certainly intend to work with the FDA to resolve this and are awaiting their response to our August 3 letter," Biomet vice president for government affairs, public affairs and corporate communication Bill Kolter told MassDevice.