K243381 is an FDA 510(k) clearance for the Total Wrist Arthroplasty System (TWA). 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 Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on November 1, 2024, 2 days after receiving the submission on October 30, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3800.
| 510(k) Number | K243381 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2024 |
| Decision Date | November 01, 2024 |
| Days to Decision | 2 days |
| Submission Type | Special |
| 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 |