Prosthesis, Wrist, Carpal Lunate
The Carpal Lunate Wrist Prosthesis is an orthopedic implant designed to replace the lunate bone of the wrist, used in the treatment of Kienbock's disease (avascular necrosis of the lunate) or severe lunate damage to restore wrist function and relieve pain. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is KWN, regulated under 21 CFR 888.3750, in the Orthopedic medical specialty. This device is an implant.
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Basic Information
- Product Code
- KWN
- Device Class
- FDA class 2
- Regulation Number
- 888.3750
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K141920 | Wrist Hemiarthroplasty System | Dec 23, 2014 | Substantially Equivalent | Arthrosurface, Inc. |
| K080997 | ASCENSION PYROCARBON LUNATE | Jun 17, 2008 | Substantially Equivalent | Ascension Orthopedics, Inc. |
| K050028 | MAESTRO CARPAL HEMIARTHROPLASTY | Mar 25, 2005 | Substantially Equivalent | Biomet Manufacturing, Inc. |
| K864491 | SWANSON TITANIUM CARPAL LUNATE IMPLANT | Apr 15, 1987 | Substantially Equivalent | Dow Corning Wright |
| K790793 | AMC R METACARPAL COMPONENT | Jun 22, 1979 | Substantially Equivalent | Howmedica Corp. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.