Zirconia Ceramic Modular Heads (Astro Met)
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K943586 FDA 510(k)
- FDA Product Code
- LZO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3353 FDA 510(k)
- Regulation Number
- 888.3353 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Zirconia Ceramic Modular Heads (Astro Met) are classified as Prosthesis, Hip, Semi-constrained, Metal/Ceramic/Polymer, designed for modular attachment to femoral components. These heads feature zirconia ceramic material, offering durability and biocompatibility for hip arthroplasty applications, with a Type I taper interface for secure fixation.
These modular heads are intended for use in orthopedic surgery settings, supplied sterile for single-use or reusable configurations depending on clinical practice. They are available in specific sizes, including 22.22mm, and must comply with MRI safety guidelines for ceramic components. Authorized under FDA 510(k) clearance (K943586), they are regulated under Class II Special Controls for hip prostheses.
Frequently asked questions
What materials are used in the Zirconia Ceramic Modular Heads?
The Zirconia Ceramic Modular Heads are made from zirconia ceramic material, which provides durability and biocompatibility for hip arthroplasty applications.
How are these modular heads attached to femoral components?
These heads feature a Type I taper interface for secure fixation to femoral components, ensuring stable attachment during hip arthroplasty procedures.
What sizes are available for the Zirconia Ceramic Modular Heads?
The Zirconia Ceramic Modular Heads are available in specific sizes, including 22.22mm, to accommodate various patient anatomies and surgical requirements.
Are these modular heads supplied sterile and are they single-use or reusable?
The Zirconia Ceramic Modular Heads are supplied sterile and can be configured for either single-use or reuse depending on clinical practice and hospital protocols.
What regulatory clearance applies to these modular heads?
These modular heads are authorized under FDA 510(k) clearance (K943586) and are regulated under Class II Special Controls for hip prostheses.
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. Sources consulted: Advanced Ceramic Solutions: Astro Met, Zirconia Ceramic Modular Heads (astro Met) 510 (k)… - FDA.report, K913420 FDA 510(k) - ZIRCONIA CERAMIC MODULAR HEADS(TYPE I T..., K991708 - ZIRCONIA 22.22MM CERAMIC MODULAR HEADS | FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K943586 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K943586 24 fields · synced Sep 19, 2026