Biomet, Inc. - FDA 510(k) Cleared Devices

Biomet, Inc. is an orthopedic medical device manufacturer based in McHenry, US. The company specializes in surgical implants, fixation systems, and trauma solutions.

Biomet has maintained a strong FDA 510(k) regulatory record since its first clearance in 1978. The company has received 419 FDA 510(k) clearances from 441 total submissions. Orthopedic devices represent 88% of its submission portfolio, reflecting the company's core focus on joint reconstruction, trauma fixation, and surgical instrumentation. The latest clearance in 2024 demonstrates continued regulatory activity and product innovation.

Recent cleared devices include K-wires, cement spacer molds for hip and shoulder procedures, distal centralizers, clavicle plating systems, and reverse shoulder implants. The company's portfolio spans fracture fixation, joint arthroplasty, and specialized orthopedic instrumentation.

Explore the complete list of Biomet FDA 510(k) cleared devices, including product names, device codes, and clearance dates in the database.

510(k) submissions have been managed by Biomet UK, Ltd. as regulatory consultant.