FDA product code KWL: Prosthesis, Hip, Hemi-, Femoral, Metal
KWL is the FDA product code for prosthesis, hip, hemi-, femoral, metal. It is a Class II device, regulated under 21 CFR 888.3360 and reviewed by the Orthopedic panel. FDA has cleared 108 510(k) submissions under KWL, 7 in the last five years, from 52 different applicants. The average 510(k) review took 109 days (median 78); 71 days on average over the last three years. FDA has posted 51 recalls for KWL devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device class | Class II |
| Regulation | 21 CFR 888.3360 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KWL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 198 |
| 2019 | 1 | 30 |
| 2020 | 1 | 77 |
| 2022 | 1 | 51 |
| 2024 | 1 | 57 |
| 2025 | 3 | 103 |
| 2026 | 2 | 52 |
Compare with all 510(k) review times · Search every KWL clearance
Top KWL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osteonics Corp. | 8 | 1999-02-24 |
| Depuy, Inc. | 7 | 1993-03-31 |
| Osteoremedies, LLC | 6 | 2026-07-24 |
| Biomet, Inc. | 6 | 1999-01-19 |
| Howmedica Corp. | 5 | 1995-11-15 |
47 more applicants have KWL clearances. See the full list in Caduvo.
Most recent KWL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262290 | Osteoremedies, LLC | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | 2026-07-24 | 18 |
| K260536 | Depuy Ireland UC | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | 2026-05-15 | 87 |
| K253675 | Osteoremedies, LLC | OsteoRemedies Hip Spacer System | 2025-12-23 | 32 |
| K252326 | Tecres S.P.A. | InterSpace GV Hip Spacer | 2025-08-06 | 12 |
| K242865 | Biocomposites, Ltd. | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | 2025-06-12 | 265 |
Recalls for KWL devices
51 product recalls in 9 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-07-30.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2024 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KWL?
KWL is the FDA product code for prosthesis, hip, hemi-, femoral, metal. It is a Class II device, regulated under 21 CFR 888.3360 and reviewed by the Orthopedic panel.
What device class is KWL?
Class II, regulation 21 CFR 888.3360. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWL?
Across 108 cleared submissions the average was 109 days from receipt to decision (median 78).
Which companies have the most KWL clearances?
Osteonics Corp. (8); Depuy, Inc. (7); Osteoremedies, LLC (6); Biomet, Inc. (6); Howmedica Corp. (5).
Have KWL devices been recalled?
Yes: 51 product recalls across 9 recall events; the most recent began 2026-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KWL
- Run a recall and safety report across every KWL manufacturer
- Watch product code KWL 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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