K191525 is an FDA 510(k) clearance for the KinematX Total Wrist Arthroplasty System. This device is classified as a Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (Class II - Special Controls, product code JWJ).
Submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on March 4, 2020, 268 days after receiving the submission on June 10, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3800.
| 510(k) Number | K191525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2019 |
| Decision Date | March 04, 2020 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JWJ — Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3800 |