Biomet has received a warning letter from the FDA regarding the signature personalized patient care (SPPC) system, alleging that the company does not have appropriate clearance or approval to market the system in the US, on 28 July 2010.
Biomet responded to the warning letter on 3 August 2010, explaining the belief of the company that the SPPC system, which is manufactured by Materialise, has been appropriately marketed under a 510(k) premarket clearance and said that it has not received a formal response to the letter from the FDA.
Biomet has been working with the FDA to resolve the issue in the best interests of patients and their doctors without disruption to patient treatment.
Headquartered in Warsaw, Indiana, Biomet and its subsidiaries design, manufacture and market products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy.
Biomet’s product portfolio encompasses reconstructive products, including orthopedic joint replacement devices, bone cements and accessories, orthobiologics and other products, such as arthroscopy products and softgoods and bracing products.