510(k) K190100 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
USTAR II System
| Applicant | United Orthopedic Corporation, Hsinchu City, TW |
| Decision | Substantially Equivalent, Sep 23, 2019 |
| Received | Jan 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2026 | United Orthopedic Corp. Brand Name: USTAR II Knee System
Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6
Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726
Software Version: N/A
P Open, Classified |
KRO | None listed |
| Feb 29, 2024 | United Orthopedic Corporation USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers:
REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, Open, Classified |
KRO | None listed |
| Feb 29, 2024 | United Orthopedic Corporation USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers:
REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE2515311 Open, Classified |
KRO | None listed |
| Feb 29, 2024 | United Orthopedic Corporation USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers:
REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE251 Open, Classified |
KRO | None listed |
| Aug 27, 2021 | Uoc Usa Inc United Orthopedics USTAR II Knee System
USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025 Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.