510(k) K082424 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
UNITED U2 TOTAL KNEE SYSTEM
| Applicant | United Orthopedic Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Dec 16, 2008 |
| Received | Aug 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082424
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2026 | United Orthopedic Corp. Brand Name: U2 Total Knee System
Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6
Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526
Software Version: N/A
Produ Open, Classified |
JWH | None listed |
| Nov 24, 2017 | United Orthopedic Corporation U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016
The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee func Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.