HAMAS PRECENTERED TOTAL WRIST
FDA 510(k) clearance K792650 · decided 1980-01-28
Clearance details
- K-number
- K792650
- Device name
- HAMAS PRECENTERED TOTAL WRIST
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-21
- Decision date
- 1980-01-28
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- JWJ
- Device class
- 2
- Regulation number
- 888.3800
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zimmer
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM (K132250) | Integra LifeSciences Corporation | 2014-03-24 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |