Biax A.F. Wrist/Biax Advanced Fixation Wrist
FDA 510(k) K031203 · DePuy Orthopaedics, Inc.
510(k) numberK031203
Submission
- Device name
- Biax A.F. Wrist/Biax Advanced Fixation Wrist
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- April 16, 2003
- Decision date
- July 14, 2003
- 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 |
| 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 |
| K030037 | Universal Total Wrist SystemJWJ · Special | Kinetikos Medical, Inc. | 02/05/2003SE |
| K021859 | Wrist ImplantJWJ · Traditional | Avanta Orthopaedics, Inc. | 12/02/2002SE |
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| K231503 | CUPTIMIZE AdvancedLLZ · Traditional | 08/22/2023SE |
| K213839 | DePuy Corail AMT Hip ProsthesisLZO · Special | 01/06/2022SE |
| K210167 | DELTA XTEND Reverse Shoulder SystemPHX · Special | 02/19/2021SE |
| K203167 | DePuy Corail AMT Hip ProsthesisLZO · Special | 11/19/2020SE |
| K202472 | ACTIS Duofix Hip ProsthesisLPH · Special | 10/21/2020SE |
| K201347 | DePuy ATTUNE Total Knee SystemOIY · Special | 06/18/2020SE |
| K193540 | TRUMATCH Personalized SolutionsJWH · Traditional | 06/16/2020SE |
| K193398 | Summit DuoFix HA CoatingMEH · Special | 02/04/2020SE |
Questions and answers
When was Biax A.F. Wrist/Biax Advanced Fixation Wrist cleared by the FDA?
Biax A.F. Wrist/Biax Advanced Fixation Wrist (K031203) received a 510(k) decision of Substantially Equivalent on July 14, 2003, 89 days after the submission was received.
What is the product code of K031203?
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.