USTAR II System
FDA 510(k) clearance K190100 · decided 2019-09-23
Clearance details
- K-number
- K190100
- Device name
- USTAR II System
- Applicant
- United Orthopedic Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-01-22
- Decision date
- 2019-09-23
- Days to decision
- 244 days
- Clearance type
- Traditional
- Product code
- KRO
- Device class
- 2
- Regulation number
- 888.3510
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hsinchu City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Tria recall (Z-2884-2026) | United Orthopedic Corp. | 2026-08-05 |
| USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference recall (Z-1215-2024) | United Orthopedic Corporation | 2024-02-29 |
| USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference num recall (Z-1216-2024) | United Orthopedic Corporation | 2024-02-29 |
| USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: recall (Z-1217-2024) | United Orthopedic Corporation | 2024-02-29 |