Biomet Metal-on-Metal Hip Systems
FDA 510(k)Class III (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K082446 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
- SESE Substantially Equivalent FDA 510(k)
This device is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for total hip arthroplasty. It features metal-on-metal articulation, intended for patients requiring hip replacement where a durable, low-friction bearing surface is required. The system includes acetabular components intended to be implanted without cement fixation.
The Biomet Metal-on-Metal Hip Systems are supplied as sterile, single-use implants for surgical use in orthopedic settings. Components are classified as Class III devices under FDA regulations and are regulated under 21 CFR 888.3330. Multiple model references are listed, including 3020282716, 3007923096, and others, reflecting variations in design and size. Storage and handling must comply with sterile surgical instrument protocols.
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 | K082446 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K082446 24 fields · synced Sep 18, 2026