WARSAW, Ind.--(BUSINESS WIRE)--Biomet announced today that the U.S. Food and Drug Administration (FDA) granted clearance of a 510(k) submission to market the Signature™ Personalized Patient Care System in the United States. The Signature™ system provides patient-matched guides for use in total knee replacement surgery paired with Biomet® implants, combining MRI or CT images for each patient with advanced surgical planning software and manufacturing techniques. The FDA granted the 510(k) clearance in a letter sent to Materialise NV, the manufacturer of the Signature™ system.
At Biomet’s request, Materialise sought the 510(k) clearance to resolve the issues the FDA raised in a Warning Letter sent to Biomet on July 27, 2010.
Jeff Binder, Biomet President and CEO, said, “Biomet cooperated fully with the FDA to resolve this matter in the best interests of patients, and we are pleased with the outcome. This clearance paves the way for future submissions on the application of Signature™ technology to the treatment of other orthopedic conditions.”
*A collaborative partnership with Materialise, N.V.
Biomet, Inc. 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, autologous therapies and dental reconstructive implants; fixation products, including electrical bone growth stimulators, internal and external orthopedic fixation devices, craniomaxillofacial implants and bone substitute materials; spinal products, including spinal stimulation devices, spinal hardware and orthobiologics; and other products, such as arthroscopy products and softgoods and bracing products. Headquartered in Warsaw, Indiana, Biomet and its subsidiaries currently distribute products in approximately 90 countries.
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