Total Wrist Arthroplasty System (TWA)
FDA 510(k) K243381 · Skeletal Dynamics, Inc.
510(k) numberK243381
Submission
- Device name
- Total Wrist Arthroplasty System (TWA)
- Applicant
- Skeletal Dynamics, Inc.
Miami, FL, US - Received
- October 30, 2024
- Decision date
- November 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWJ – Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3800
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233574 | Total Wrist Arthroplasty System (TWA)JWJ · Traditional | Skeletal Dynamics | 07/03/2024SE |
| K233674 | Freedom Wrist Arthroplasty SystemJWJ · Traditional | Ascension Orthopedics, Inc. | 05/30/2024SE |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty SystemJWJ · Traditional | Arthrosurface, Inc. | 10/15/2020SE |
| K191525 | KinematX Total Wrist Arthroplasty SystemJWJ · Traditional | Extremity Medical, LLC | 03/04/2020SE |
| K132250 | Integra Freedom Wrist Arthroplasty SystemJWJ · Traditional | Integra LifeSciences Corporation | 03/24/2014SE |
| K080426 | Maestro Wrist Fracture ImplantJWJ · Traditional | Biomet Manufacturing Corp | 07/29/2008SE |
| K042032 | Maestro Total WristJWJ · Traditional | Biomet, Inc. | 10/07/2004SE |
| K031203 | Biax A.F. Wrist/Biax Advanced Fixation WristJWJ · Traditional | DePuy Orthopaedics, Inc. | 07/14/2003SE |
| K030037 | Universal Total Wrist SystemJWJ · Special | Kinetikos Medical, Inc. | 02/05/2003SE |
| K021859 | Wrist ImplantJWJ · Traditional | Avanta Orthopaedics, Inc. | 12/02/2002SE |
More from Avanta Orthopaedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261770 | Suture Button Repair SystemMBI · Traditional | 07/29/2026SE |
| K254288 | Clavicle Fixation SystemHRS · Abbreviated | 03/23/2026SE |
| K252949 | Geminus Volar Distal Radius Plating SystemHRS · Traditional | 11/13/2025SE |
| K242436 | Proximal Humerus Fixation SystemHRS · Traditional | 11/14/2024SE |
| K241815 | Protean Fragment Plating SystemHRS · Traditional | 09/26/2024SE |
| K242055 | Freefix Forearm Plating SystemHRS · Special | 08/01/2024SE |
| K240835 | Suture Button Repair SystemMBI · Traditional | 07/19/2024SE |
| K233574 | Total Wrist Arthroplasty System (TWA)JWJ · Traditional | 07/03/2024SE |
| K231447 | Double Internal Joint Stabilizer- ElbowOZI · Traditional | 12/15/2023SE |
| K231188 | ALIGN Radial Head SystemKWI · Traditional | 09/28/2023SE |
Questions and answers
When was Total Wrist Arthroplasty System (TWA) cleared by the FDA?
Total Wrist Arthroplasty System (TWA) (K243381) received a 510(k) decision of Substantially Equivalent on November 1, 2024, 2 days after the submission was received.
What is the product code of K243381?
The FDA product code is JWJ – Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained, a Class II (moderate risk) device regulated under 21 CFR 888.3800.