K160461 is an FDA 510(k) clearance for the Arthrex iBalance BiCompartmental Arthroplasty System. This device is classified as a Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code KRR).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on April 12, 2016, 53 days after receiving the submission on February 19, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3540.
| 510(k) Number | K160461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2016 |
| Decision Date | April 12, 2016 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KRR — Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3540 |