Hsinchu City, TW · 13 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 4 | 2025-09-25 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 3 | 2025-01-06 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | 2 | 2025-07-31 |
| KRO | — | — | — | 1 | 2025-08-22 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | 1 | 2025-05-01 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 1 | 2022-11-04 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | 1 | 2020-01-03 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-01-03 | Class II | Ongoing | Z-1217-2024 | USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - … | — | Their is a potential that the implant curved stem may be oriented incorrectly. |
| 2024-01-03 | Class II | Ongoing | Z-1216-2024 | USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x1… | — | Their is a potential that the implant curved stem may be oriented incorrectly. |
| 2024-01-03 | Class II | Ongoing | Z-1215-2024 | USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - … | — | Their is a potential that the implant curved stem may be oriented incorrectly. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-09-25 | K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | JWH | Class II | Orthopedic |
| 2025-08-22 | K252303 | Stem Extension Line (USTAR II System) | KRO | — | — |
| 2025-07-31 | K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | MBH | Class II | Orthopedic |
| 2025-05-01 | K242315 | Resolve Modular Revision Hip Stem | MEH | Class II | Orthopedic |
| 2025-01-06 | K243466 | Conformity Stem Extension Line, #0 | LZO | Class II | Orthopedic |
| 2024-12-20 | K243024 | Cellbrick Knee Spacer | JWH | Class II | Orthopedic |
| 2024-08-30 | K242249 | Conformity Stem Extension Line | LZO | Class II | Orthopedic |
| 2023-02-28 | K221705 | U2 Total Knee System-PF+ | MBH | Class II | Orthopedic |
| 2023-01-05 | K221149 | U-Motion II Acetabular System-Extension line | LZO | Class II | Orthopedic |
| 2022-11-04 | K221675 | United U2 femoral head, 22mm delta ceramic head | LPH | Class II | Orthopedic |
| 2022-10-06 | K222700 | Tibial baseplate, Tibial insert | JWH | Class II | Orthopedic |
| 2021-04-21 | K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS | JWH | Class II | Orthopedic |
| 2020-01-03 | K191056 | Conformity stem, cemented | JDI | Class II | Orthopedic |