FDA applicant
Biomet Sports Medicine
FDA records 13 decisions for Biomet Sports Medicine (Warsaw, IN) from 2007 to 2014: 13 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Its devices cite 39 predicates, 3 of them its own earlier devices. 19 recalls are linked to its devices.
FDA’s records also spell it “Biomet Sports Medicine, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biomet Sports Medicine’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Biomet Sports Medicine’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Biomet”
FDA records each applicant name separately; these may or may not be the same firm.