KWN · Prosthesis, Wrist, Carpal Lunate
Orthopedic · 21 CFR 888.3750 · Class 2
Overview
| Product Code | KWN |
|---|---|
| Device Name | Prosthesis, Wrist, Carpal Lunate |
| Regulation | 21 CFR 888.3750 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist.
Classification Rationale
Class II.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | Dec 23, 2014 | SESE |
| K080997 | ASCENSION PYROCARBON LUNATE | Ascension Orthopedics, Inc. | Jun 17, 2008 | SESE |
| K050028 | MAESTRO CARPAL HEMIARTHROPLASTY | Biomet Manufacturing, Inc. | Mar 25, 2005 | SESE |
| K864491 | SWANSON TITANIUM CARPAL LUNATE IMPLANT | Dow Corning Wright | Apr 15, 1987 | SESE |
| K790793 | AMC R METACARPAL COMPONENT | Howmedica Corp. | Jun 22, 1979 | SESE |
Top Applicants
- Howmedica Corp. — 1 clearance
- Dow Corning Wright — 1 clearance
- Biomet Manufacturing, Inc. — 1 clearance
- Ascension Orthopedics, Inc. — 1 clearance
- Arthrosurface, Inc. — 1 clearance
