Amplitude Surgical Receives 510(k) for Anatomic Knee

By Julie A. Vetalice

Amplitude Surgical received FDA 510(k) clearance to market the Anatomic® implant for the treatment of degenerative knee disease.

The company filed for 510(k) clearance of the device in 2Q16, at which time it had been used in >17,000 procedures in ex-U.S. launch. To date, that number has increased to >20,000 procedures.

The company will now proceed to launch its U.S. subsidiary, Amplitude Orthopedics Corp. Amplitude claims close to 15% of the French market for knee implants, ranking second in the country behind Zimmer Biomet, and ahead of DePuy, Stryker and Smith & Nephew in the region.

Sources: Amplitude Surgical; ORTHOWORLD Inc.

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory