Biolox Delta Ceramic Heads, Biolox Delta Option Ceramic Heads
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192683 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 Biolox Delta Ceramic Heads and Biolox Delta Option Ceramic Heads are classified as ceramic femoral heads for total hip arthroplasty, designed to articulate with acetabular components in hip replacement procedures. These devices are engineered from high-performance ceramic materials, offering low friction and wear resistance to enhance long-term durability and reduce the risk of adverse reactions to wear debris. The Biolox Delta Option variant provides additional design flexibility for surgical applications. Both products are intended for use in both cemented and non-cemented femoral and acetabular implants, addressing degenerative joint conditions.
These ceramic heads are supplied as single-use, sterile components, intended for use in orthopedic surgical settings. They are compatible with MRI environments and are available in standard sizes as specified in the product documentation. The devices are regulated under the FDA 510(k) clearance process, with the Biolox Delta Ceramic Heads and Biolox Delta Option Ceramic Heads classified under product code LZO for orthopedic implants. Storage and handling must adhere to sterile medical device protocols to ensure integrity prior to surgical use.
Frequently asked questions
What are Biolox Delta Ceramic Heads used for?
Biolox Delta Ceramic Heads are designed for total hip arthroplasty, serving as the femoral component that articulates with acetabular implants. They are specifically engineered to address degenerative joint conditions by providing a durable, low-friction surface that minimizes wear and reduces the risk of adverse reactions from debris. The Biolox Delta Option variant offers additional design flexibility to accommodate various surgical needs.
Are Biolox Delta Ceramic Heads single-use or reusable?
These ceramic heads are intended for single-use only. As sterile components, they are supplied pre-sterilized for immediate surgical use, ensuring patient safety and compliance with medical device protocols. Reuse is not recommended due to potential contamination and degradation of performance over multiple uses.
What sizes are available for Biolox Delta Ceramic Heads?
The Biolox Delta Ceramic Heads come in standard sizes as detailed in the product documentation. While exact dimensions are not provided here, these sizes are designed to match common femoral implant systems used in hip replacement surgeries. For precise sizing, refer to the manufacturer’s technical specifications or surgical planning tools.
How should Biolox Delta Ceramic Heads be stored?
These devices must be stored according to sterile medical device protocols to maintain their integrity before use. They should be kept in their original packaging, protected from moisture, dust, and physical damage. Storage conditions should comply with the manufacturer’s guidelines to ensure sterility and functionality until surgery.
Are Biolox Delta Ceramic Heads compatible with MRI environments?
Yes, Biolox Delta Ceramic Heads are compatible with MRI environments. This makes them suitable for patients who may require MRI scans post-surgery, as ceramic materials do not interfere with magnetic resonance imaging. Always verify compatibility with your specific MRI equipment and protocols, as individual systems may have variations.
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: BIOLOX® Ceramic Implants | 25M+ Surgeries & 50 Years of Expertise, BIOLOX®delta Ceramic Hip Heads | MicroPort Orthopedics, Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192683 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet Uk Ltd
- FDA Applicant
- Biomet UK, Ltd.
Sources (1)
- FDA 510(k) K192683 24 fields · synced Oct 1, 2026