FDA applicant
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
FDA records 11 decisions for Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (Mahwah, NJ) from 2016 to 2023: 11 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and HSX (Prosthesis, Knee, Femorotibial…). Since 2016 its 510(k)s took a median of 120 days from receipt to decision, against 157 for FDA’s reviews in the same codes and years. Its devices cite 34 predicates, 3 of them its own earlier devices. 23 recalls are linked to its devices.
FDA’s records also spell it “Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
18in 2024
Class I Class II/III not classified
Planning a device like Howmedica Osteonics Corp. A.K.A.…’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 “Howmedica”
FDA records each applicant name separately; these may or may not be the same firm.