INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
FDA 510(k) clearance K132250 · decided 2014-03-24
Clearance details
- K-number
- K132250
- Device name
- INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2013-07-19
- Decision date
- 2014-03-24
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- JWJ
- Device class
- 2
- Regulation number
- 888.3800
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Total Wrist Arthroplasty System (TWA) (K243381) | Skeletal Dynamics, Inc. | 2024-11-01 |
| Total Wrist Arthroplasty System (TWA) (K233574) | Skeletal Dynamics | 2024-07-03 |
| Freedom Wrist Arthroplasty System (K233674) | Ascension Orthopedics, Inc. | 2024-05-30 |
| Arthrosurface WristMotion Total Wrist Arthroplasty System (K200718) | Arthrosurface, Inc. | 2020-10-15 |
| KinematX Total Wrist Arthroplasty System (K191525) | Extremity Medical, LLC | 2020-03-04 |
| MAESTRO WRIST FRACTURE IMPLANT (K080426) | Biomet Manufacturing Corp | 2008-07-29 |
| MAESTRO TOTAL WRIST (K042032) | Biomet, Inc. | 2004-10-07 |
| BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST (K031203) | DePuy Orthopaedics, Inc. | 2003-07-14 |
| UNIVERSAL TOTAL WRIST SYSTEM (K030037) | Kinetikos Medical, Inc. | 2003-02-05 |
| WRIST IMPLANT (K021859) | Avanta Orthopaedics, Inc. | 2002-12-02 |
| MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM (K020554) | Kinetikos Medical, Inc. | 2002-05-03 |
| PASCO MIC AND MIC/ID PANELS/ CEFDINIR (K982156) | Pasco Laboratories, Inc. | 1998-07-29 |
Recalls involving this device
No recalls on record reference this clearance.