FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
K Number: K031203
·
Decision Jul 14, 2003
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
207
Review Days
89
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
- K Number
- K031203
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Orthopaedics, Inc.
- Date Received
- April 16, 2003
- Decision Date
- July 14, 2003
- Product Code
- JWJ
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWJ), ordered by most recent decision date.
Total Wrist Arthroplasty System (TWA)
FDA 510(k)
FDA Class 2
·Orthopedic
Total Wrist Arthroplasty System (TWA)
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Wrist Arthroplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrosurface WristMotion Total Wrist Arthroplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
KinematX Total Wrist Arthroplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by DePuy Orthopaedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252887 | DePuy ATTUNE Knee System | May 22, 2026 | Substantially Equivalent |
| K231503 | CUPTIMIZE Advanced | Aug 22, 2023 | Substantially Equivalent |
| K213839 | DePuy Corail AMT Hip Prosthesis | Jan 6, 2022 | Substantially Equivalent |
| K210167 | DELTA XTEND Reverse Shoulder System | Feb 19, 2021 | Substantially Equivalent |
| K203167 | DePuy Corail AMT Hip Prosthesis | Nov 19, 2020 | Substantially Equivalent |
| K202472 | ACTIS Duofix Hip Prosthesis | Oct 21, 2020 | Substantially Equivalent |
| K201347 | DePuy ATTUNE Total Knee System | Jun 18, 2020 | Substantially Equivalent |
| K193540 | TRUMATCH Personalized Solutions | Jun 16, 2020 | Substantially Equivalent |
| K193398 | Summit DuoFix HA Coating | Feb 4, 2020 | Substantially Equivalent |
| K192946 | DePuy Corail AMT Hip Prosthesis | Nov 26, 2019 | Substantially Equivalent |