Ringloc Hybrid Acetabular System
FDA 510(k)Class III (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K093235 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)
The Ringloc Hybrid Acetabular System is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for hip arthroplasty. It combines a metal acetabular shell with a polyethylene liner to provide structural support and articulation in total hip replacements, offering stability through a hybrid fixation approach.
This system is intended for use in orthopedic surgical settings and is supplied as a reusable medical device. It is classified as Class III under FDA regulations and requires FDA 510(k) clearance. The system is not MRI-safe and must be handled according to sterile surgical protocols, with specific sizes and configurations referenced by unique FEI numbers for inventory and procedural planning.
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 | K093235 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K093235 24 fields · synced Sep 18, 2026