K161060 is an FDA 510(k) clearance for the Arthrex iBalance UKA System Vitamin E Tibial Bearing. This device is classified as a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HSX).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on December 15, 2016, 244 days after receiving the submission on April 15, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3520.
| 510(k) Number | K161060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2016 |
| Decision Date | December 15, 2016 |
| Days to Decision | 244 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3520 |