FDA product code KWN: Prosthesis, Wrist, Carpal Lunate
KWN is the FDA product code for prosthesis, wrist, carpal lunate. It is a Class II device, regulated under 21 CFR 888.3750 and reviewed by the Orthopedic panel. FDA has cleared 5 510(k) submissions under KWN, from 5 different applicants. The average 510(k) review took 104 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Wrist, Carpal Lunate |
| Device class | Class II |
| Regulation | 21 CFR 888.3750 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every KWN clearance
Top KWN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrosurface, Inc. | 1 | 2014-12-23 |
| Ascension Orthopedics, Inc. | 1 | 2008-06-17 |
| Biomet Manufacturing, Inc. | 1 | 2005-03-25 |
| Dow Corning Wright | 1 | 1987-04-15 |
| Howmedica Corp. | 1 | 1979-06-22 |
Most recent KWN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141920 | Arthrosurface, Inc. | Wrist Hemiarthroplasty System | 2014-12-23 | 160 |
| K080997 | Ascension Orthopedics, Inc. | ASCENSION PYROCARBON LUNATE | 2008-06-17 | 70 |
| K050028 | Biomet Manufacturing, Inc. | MAESTRO CARPAL HEMIARTHROPLASTY | 2005-03-25 | 78 |
| K864491 | Dow Corning Wright | SWANSON TITANIUM CARPAL LUNATE IMPLANT | 1987-04-15 | 153 |
| K790793 | Howmedica Corp. | AMC R METACARPAL COMPONENT | 1979-06-22 | 59 |
Recalls for KWN devices
openFDA lists no recalls for product code KWN.
Frequently asked questions
What is FDA product code KWN?
KWN is the FDA product code for prosthesis, wrist, carpal lunate. It is a Class II device, regulated under 21 CFR 888.3750 and reviewed by the Orthopedic panel.
What device class is KWN?
Class II, regulation 21 CFR 888.3750. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWN?
Across 5 cleared submissions the average was 104 days from receipt to decision (median 78).
Which companies have the most KWN clearances?
Arthrosurface, Inc. (1); Ascension Orthopedics, Inc. (1); Biomet Manufacturing, Inc. (1); Dow Corning Wright (1); Howmedica Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KWN
- Run a recall and safety report across every KWN manufacturer
- Watch product code KWN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times