FDA applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
FDA records 34 decisions for Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Mahwah, NJ) from 2010 to 2026: 34 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 69 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 164 predicates, 31 of them its own earlier devices. 7 recalls are linked to its devices.
FDA’s records also spell it “Howmedica Osteonics Corp (Dba Stryker Orthopaedics)”, “Howmedica Osteonics, Dba Stryker Orthopaedics”, “Howmedica Osteonics Corp. dba Stryker Orthopaedics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Howmedica Osteonics Corp., Dba Stryker Orthopaedics’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
5in 2026
Class I Class II/III not classified
Planning a device like Howmedica Osteonics Corp., Dba Stryker…’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.