FDA applicant
Howmedica Osteonics Corp.
FDA records 303 decisions for Howmedica Osteonics Corp. (Allendale, NJ) from 1997 to 2020: 301 510(k) clearances and 2 original PMA approvals. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and JWH (Prosthesis, Knee, Patellofemorotibial…). Its devices cite 302 predicates, 129 of them its own earlier devices. 281 recalls are linked to its devices.
FDA’s records also spell it “Howmedica Osteonics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Howmedica Osteonics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
9in 2026
Class I Class II/III not classified
Planning a device like Howmedica Osteonics 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 “Howmedica”
FDA records each applicant name separately; these may or may not be the same firm.