KWL
- Product code
- KWL
- Device name
- Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3360
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 108
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K262290 | 2026-07-24 | Osteoremedies, LLC | REMEDY POLY+PLUS SNAP FIT Acetabular Cup summary |
| K260536 | 2026-05-15 | Depuy Ireland UC | Prostalac Hip System, SmartSet V+G Dual Antibiotic B summary |
| K253675 | 2025-12-23 | Osteoremedies, LLC | OsteoRemedies Hip Spacer System summary |
| K252326 | 2025-08-06 | Tecres S.P.A. | InterSpace GV Hip Spacer summary |
| K242865 | 2025-06-12 | Biocomposites, Ltd. | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Sho summary |
| K234028 | 2024-02-15 | Heraeus Medical GmbH | COPAL® exchange G hip spacer; COPAL® G+V summary |
Official FDA classification page: KWL
Classification and pathway per current FDA publications. Data from openFDA (CC0).