FDA applicant
Osteonics Corp.
FDA records 178 decisions for Osteonics Corp. (Allendale, NJ) from 1980 to 2000: 178 510(k) clearances. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and MEH (Prosthesis, Hip, Semi-Constrained, Uncemented…). Its devices cite 12 predicates, 5 of them its own earlier devices. 131 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Osteonics Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Osteonics Corp. since 2007.
Recalls per year
4in 2026
Class I Class II/III not classified
Planning a device like 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 “Osteonics”
FDA records each applicant name separately; these may or may not be the same firm.