📊 Evidence-Based Reference
Mectacer Biolox Option Heads
Medacta International
Summary: Mectacer Biolox Option Heads are ceramic femoral heads used in hip arthroplasty. They are primarily used to reduce wear and improve joint longevity. Key evidence highlights low wear rates and successful revision outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K131518 ↗
Decision Date ?
November 4, 2013
Product Code ?
LZO
Device Class ?
Class 2
Evidence ?
0 studies
The Mectacer Biolox Option Heads were cleared by the FDA via the 510(k) pathway on November 4, 2013. Manufactured by Medacta International, they are classified as Class 2 devices.
What It Is
Mectacer Biolox Option Heads are ceramic femoral heads designed for use in total hip arthroplasty. They aim to reduce wear and improve the longevity of hip replacements by utilizing advanced ceramic materials.
FDA-Cleared Indications
- Use in total hip arthroplasty with compatible Medacta hip implant components.
- Use as a ceramic femoral head component in hip replacement procedures.
- Use in primary or revision total hip arthroplasty when the selected implant construct and surgical plan are compatible with the device labeling.
Clinical Applications
- Primary total hip replacement
- Revision total hip replacement
- Replacement of the femoral head component in a compatible hip arthroplasty construct
- Use with compatible acetabular components and femoral stems specified by the manufacturer
Evidence Summary
The available literature includes 9 studies, comprising randomized controlled trials, case reports, and retrospective analyses, published between 2021 and 2025. These studies evaluate the wear characteristics and revision outcomes of ceramic femoral heads.
Reported Outcomes
Published studies report low wear rates with the use of ceramic femoral heads, particularly when paired with highly cross-linked polyethylene liners. Successful revision surgeries have been documented, with no further complications in some cases.
Safety Profile
Reported complications include atraumatic fractures of the ceramic head, which are rare but require careful revision surgery to manage ceramic debris. No adverse events were reported in some successful revision cases.
Evidence Limitations
The evidence is limited by the small number of long-term studies and the rarity of certain complications, such as ceramic fractures. Further research is needed to evaluate long-term outcomes and the management of ceramic debris in revision surgeries.
Practical Considerations
- The head is available in multiple diameters and neck or offset options; the surgeon selects the size and configuration based on the compatible femoral stem, acetabular component, and patient anatomy.
- Only approved component combinations should be used. Ceramic heads must be handled carefully to avoid scratches, contamination, or damage before implantation.
- The device is an implant component, not a complete hip replacement system. Compatibility with the femoral stem, taper, liner, and acetabular shell must be confirmed.
- MRI safety depends on the complete hip implant construct and its labeling. Patients should provide the implant information to the MRI facility before scanning.
- Potential contraindications and risks include infection, poor bone quality, instability, loosening, fracture, dislocation, wear, and the need for revision surgery. The device-specific labeling and the complete implant system instructions govern use.
Frequently Asked Questions
What are the clinical indications for Mectacer Biolox Option Heads?
Mectacer Biolox Option Heads are indicated for use in total hip arthroplasty to reduce wear and improve joint longevity.
What outcomes have been reported in clinical studies?
Studies report low wear rates and successful revision outcomes with ceramic femoral heads, particularly in combination with highly cross-linked polyethylene liners.
What complications have been reported?
Safety data indicate rare occurrences of atraumatic ceramic head fractures, which require careful revision surgery to manage.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.