36mm Biolox Delta Ceramic Heads
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K061312 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 36MM BIOLOX DELTA CERAMIC HEADS are modular ceramic hip prosthesis components designed as a bearing surface in total hip arthroplasty. They articulate with polyethylene acetabular liners and attach to metallic femoral stems via a Biomet Type I taper.
These ceramic heads are supplied as single-use components and are intended for use in clinical and surgical settings by orthopedic surgeons. The device is not specified as sterile, and its regulatory status is based on FDA 510(k) clearance (K061312) under product code LZO.
Frequently asked questions
What are the 36MM BIOLOX DELTA Ceramic Heads used for?
These modular ceramic heads serve as the bearing surface in total hip arthroplasty, articulating with polyethylene acetabular liners and attaching to metallic femoral stems.
How are the 36MM BIOLOX DELTA Ceramic Heads supplied?
The ceramic heads are supplied as single-use components intended for use in clinical and surgical settings by orthopedic surgeons.
Is the 36MM BIOLOX DELTA Ceramic Head sterile?
No, the device is not specified as sterile.
What is the regulatory status of the 36MM BIOLOX DELTA Ceramic Heads?
The device has FDA 510(k) clearance (K061312) under product code LZO.
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: 36MM BIOLOX DELTA CERAMIC HEADS (K061312) - Innolitics, 36MM BIOLOX DELTA CERAMIC HEADS (K061312) - FDA 510 (k), BIOLOX delta Ceramic - KYOCERA Medical Technologies, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061312 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K061312 24 fields · synced Sep 25, 2026