K190100 is an FDA 510(k) clearance for the USTAR II System. This device is classified as a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II - Special Controls, product code KRO).
Submitted by United Orthopedic Corporation (Hsinchu City, TW). The FDA issued a Cleared decision on September 23, 2019, 244 days after receiving the submission on January 22, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3510.
| 510(k) Number | K190100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2019 |
| Decision Date | September 23, 2019 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3510 |