FDA applicant
Biomet Orthopedics, Inc.
FDA records 41 decisions for Biomet Orthopedics, Inc. (Warsaw, IN) from 2000 to 2026: 41 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 258 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 83 predicates, 3 of them its own earlier devices. 13 recalls are linked to its devices.
FDA’s records also spell it “Biomet Orthopedics”, “Biomet Orthopedics, LLC”, “Biomet Orthopedics Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biomet Orthopedics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
2in 2019
Class I Class II/III not classified
Planning a device like Biomet Orthopedics, 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.