FDA applicant
Biomet Manufacturing Corp
FDA records 129 decisions for Biomet Manufacturing Corp (Warsaw, IN) from 1999 to 2023: 128 510(k) clearances and 1 original PMA approval. Most are in product codes PHX (Shoulder Prosthesis, Reverse Configuration) and KWA (Prosthesis, Hip, Semi-Constrained (Metal…). Since 2016 its 510(k)s took a median of 143 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 362 predicates, 53 of them its own earlier devices. 217 recalls are linked to its devices.
FDA’s records also spell it “Biomet Manufacturing, Inc.”, “Biomet Manufacturing, LLC”, “Biomet Manufacturing”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biomet Manufacturing Corp’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Biomet Manufacturing Corp’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.