Freedom Wrist Arthroplasty System
FDA 510(k) K233674 · Ascension Orthopedics, Inc.
510(k) numberK233674
Submission
- Device name
- Freedom Wrist Arthroplasty System
- Applicant
- Ascension Orthopedics, Inc.
Austin, TX, US - Received
- November 16, 2023
- Decision date
- May 30, 2024
- 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 |
| 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 |
|---|---|---|
| K233670 | Ascension Silicone MCP; Ascension Silicone PIPKYJ · Special | 12/14/2023SE |
| K182878 | Integra Salto Total Ankle SystemHSN · Special | 12/18/2018SE |
| K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation SystemHWC · Traditional | 07/14/2017SE |
| K160830 | Integra External Fixation SystemKTT · Special | 07/06/2016SE |
| K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidKWS · Traditional | 12/23/2015SE |
| K152527 | Integra DigiFuse Cannulated Intramedullary Fusion SystemHWC · Traditional | 10/29/2015SE |
| K151459 | Integra Total Ankle Replacement SystemHSN · Traditional | 08/31/2015SE |
| K142413 | TITAN Modular Total Shoulder SystemKWS · Traditional | 11/14/2014SE |
| K121826 | Integra Proximal Humeral Plate SystemHRS · Traditional | 02/13/2013SE |
| K110700 | Ascension Atlas Humeral Plating SystemHRS · Traditional | 12/06/2011SE |
Questions and answers
When was Freedom Wrist Arthroplasty System cleared by the FDA?
Freedom Wrist Arthroplasty System (K233674) received a 510(k) decision of Substantially Equivalent on May 30, 2024, 196 days after the submission was received.
What is the product code of K233674?
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.