FDA applicant
United Orthopedic Corporation
FDA records 61 decisions for United Orthopedic Corporation (Hsinchu, TW) from 2000 to 2026: 61 510(k) clearances. 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 244 days from receipt to decision, against 118 for FDA’s reviews in the same codes and years. Its devices cite 216 predicates, 122 of them its own earlier devices. 16 recalls are linked to its devices.
FDA’s records also spell it “United Orthopedic Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided United Orthopedic Corporation’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like United Orthopedic Corporation’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) Report