FDA applicant
Biomet, Inc.
FDA records 446 decisions for Biomet, Inc. (Warsaw, IN) from 1978 to 2026: 445 510(k) clearances and 1 original PMA approval. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and LPH (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 573 predicates, 270 of them its own earlier devices. 338 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Biomet”, “Biomet Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biomet, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
4in 2024
Class I Class II/III not classified
Planning a device like Biomet, Inc.’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.