FDA product code KWA: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
KWA is the FDA product code for prosthesis, hip, semi-constrained (metal uncemented acetabular component). It is a Class III device, regulated under 21 CFR 888.3330 and reviewed by the Orthopedic panel. FDA has cleared 114 510(k) submissions under KWA, from 29 different applicants. The average 510(k) review took 119 days (median 90). FDA has posted 203 recalls for KWA devices, 20 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
| Device class | Class III |
| Regulation | 21 CFR 888.3330 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every KWA clearance
Top KWA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wrightmedicaltechnologyinc | 26 | 2012-10-11 |
| Biomet Manufacturing Corp | 13 | 2011-09-30 |
| DePuy Orthopaedics, Inc. | 12 | 2009-03-06 |
| Biomet, Inc. | 11 | 2010-09-03 |
| Zimmer GmbH | 5 | 2011-10-07 |
24 more applicants have KWA clearances. See the full list in Caduvo.
Most recent KWA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122778 | Wrightmedicaltechnologyinc | PROFEMUR Z REVISION HIP STEM | 2012-10-11 | 30 |
| K121544 | Wrightmedicaltechnologyinc | DYNASTY BIOFOAM SHELL | 2012-07-30 | 66 |
| K113271 | Biomet Manufacturing, Inc. | METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS | 2012-05-18 | 196 |
| K113322 | Wrightmedicaltechnologyinc | CONSERVE THIN SHELL | 2012-02-03 | 85 |
| K112080 | Wrightmedicaltechnologyinc | PRESERVE HIP STEM | 2011-12-28 | 160 |
Recalls for KWA devices
203 product recalls in 26 recall events; 20 initiated in the last five years and 20 still open. Most recent: 2023-10-09.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 17 |
| 2023 | 20 |
Frequently asked questions
What is FDA product code KWA?
KWA is the FDA product code for prosthesis, hip, semi-constrained (metal uncemented acetabular component). It is a Class III device, regulated under 21 CFR 888.3330 and reviewed by the Orthopedic panel.
What device class is KWA?
Class III, regulation 21 CFR 888.3330. Typical premarket route: PMA.
How long does a 510(k) take for product code KWA?
Across 114 cleared submissions the average was 119 days from receipt to decision (median 90).
Which companies have the most KWA clearances?
Wrightmedicaltechnologyinc (26); Biomet Manufacturing Corp (13); DePuy Orthopaedics, Inc. (12); Biomet, Inc. (11); Zimmer GmbH (5).
Have KWA devices been recalled?
Yes: 203 product recalls across 26 recall events; the most recent began 2023-10-09.
Next steps
- Run an FDA pathway report with predicate devices for product code KWA
- Run a recall and safety report across every KWA manufacturer
- Watch product code KWA 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.
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