KinematX Total Wrist Arthroplasty System
FDA 510(k) K191525 · Extremity Medical, LLC
510(k) numberK191525
Submission
- Device name
- KinematX Total Wrist Arthroplasty System
- Applicant
- Extremity Medical, LLC
Parsippany, NJ, US - Received
- June 10, 2019
- Decision date
- March 4, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|---|
| K243381 | Total Wrist Arthroplasty System (TWA)JWJ · Special | Skeletal Dynamics, Inc. | 11/01/2024SE |
| 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 |
| 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 |
|---|---|---|
| K250536 | MetaFore Small Screw SystemHWC · Traditional | 10/08/2025SE |
| K251128 | Extremity Medical External Fixation SystemKTT · Special | 05/07/2025SE |
| K241563 | Extremity Medical External Fixation SystemKTT · Traditional | 02/21/2025SE |
| K212297 | Omni Foot and Ankle Plating SystemHRS · Special | 08/20/2021SE |
| K211261 | Axis Charcot Fixation SystemHWC · Special | 05/28/2021SE |
| K201556 | Intraosseous Fixation SystemHWC · Special | 07/08/2020SE |
| K192592 | Axis Plating SystemHRS · Traditional | 11/21/2019SE |
| K181067 | AlignX Ankle Fusion SystemHRS · Special | 05/23/2018SE |
| K180808 | Omni Foot Plating SystemHRS · Traditional | 05/22/2018SE |
| K172260 | Omni Foot Plating SystemHRS · Traditional | 11/06/2017SE |
Questions and answers
When was KinematX Total Wrist Arthroplasty System cleared by the FDA?
KinematX Total Wrist Arthroplasty System (K191525) received a 510(k) decision of Substantially Equivalent on March 4, 2020, 268 days after the submission was received.
What is the product code of K191525?
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.