United Orthopedic Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 40
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1216-2024 | Class II | USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: R | January 3, 2024 |
| Z-1215-2024 | Class II | USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: | January 3, 2024 |
| Z-1217-2024 | Class II | USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153 | January 3, 2024 |
| Z-1129-2018 | Class II | U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total K | November 24, 2017 |
| Z-1128-2018 | Class II | U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 | November 24, 2017 |
| Z-1692-2017 | Class II | UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for | February 10, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | September 25, 2025 |
| K252303 | Stem Extension Line (USTAR II System) | August 22, 2025 |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | July 31, 2025 |
| K242315 | Resolve Modular Revision Hip Stem | May 1, 2025 |
| K243466 | Conformity Stem Extension Line, #0 | January 6, 2025 |
| K243024 | Cellbrick Knee Spacer | December 20, 2024 |
| K242249 | Conformity Stem Extension Line | August 30, 2024 |
| K221705 | U2 Total Knee System-PF+ | February 28, 2023 |
| K221149 | U-Motion II Acetabular System-Extension line | January 5, 2023 |
| K221675 | United U2 femoral head, 22mm delta ceramic head | November 4, 2022 |
| K222700 | Tibial baseplate, Tibial insert | October 6, 2022 |
| K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS | April 21, 2021 |
| K191056 | Conformity stem, cemented | January 3, 2020 |
| K190100 | USTAR II System | September 23, 2019 |
| K183312 | Conformity Stem | August 8, 2019 |
| K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | June 12, 2018 |
| K172251 | UTS Stem | October 24, 2017 |
| K170089 | U-Motion II Acetabular System Additional sizes | October 6, 2017 |
| K163441 | Locking Cage, Full XPE Cup | August 25, 2017 |
| K162957 | U2 Femoral Head | July 17, 2017 |