FDA applicant
Zimmer, Inc.
FDA records 426 decisions for Zimmer, Inc. (Warsaw, IN) from 1976 to 2026: 423 510(k) clearances and 3 original PMA approvals. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LPH (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 757 predicates, 470 of them its own earlier devices. 795 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Zimmer GmbH”, “Zimmer”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zimmer, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Zimmer, 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 “Zimmer”
FDA records each applicant name separately; these may or may not be the same firm.