ATH Metal:UHMWPE Total Hip System
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K882675 FDA 510(k)
- FDA Product Code
- KWA FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3330 FDA 510(k)
- Regulation Number
- 888.3330 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SN FDA 510(k)
This device is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for total hip arthroplasty. It combines a metal acetabular component with ultra-high-molecular-weight polyethylene (UHMWPE) to replace the natural hip joint, restoring mobility and function in patients with degenerative joint disease or trauma.
The system is intended for surgical use in orthopedic settings and is supplied as a sterile, single-use implant. Components are MRI-unsafe due to the metal construction and must be handled with sterile techniques. Multiple sizes and configurations are available, as referenced by the listed FEI numbers, and the device carries FDA 510(k) clearance under regulation 888.3330 for orthopedic applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K882675 | Class III | Active |
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Manufacturer
- Manufacturer
- Kinamed, Inc.
Sources (1)
- FDA 510(k) K882675 24 fields · synced Sep 18, 2026