đź“Š Evidence-Based Reference
Mectacer Biolox Forte-Femoral Heads
Medacta International
Summary: The mectacer biolox forte-femoral heads are ceramic components used in hip arthroplasty. They are primarily used for their high strength and low wear properties. Key evidence highlights their durability but notes potential fracture risks.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K073337 ↗
Decision Date ?
February 13, 2008
Product Code ?
LZO
Device Class ?
Class 2
Evidence ?
0 studies
The mectacer biolox forte-femoral heads were cleared by the FDA via the 510(k) pathway on February 13, 2008. Manufactured by Medacta International, they are classified as Class 2 devices.
What It Is
The mectacer biolox forte-femoral heads are ceramic femoral head components used in total hip arthroplasty. They are designed to provide high strength and wear resistance, reducing the risk of osteolysis and improving joint longevity.
FDA-Cleared Indications
- Use as a femoral head component in total hip arthroplasty.
- Use with compatible hip prosthesis components according to the manufacturer’s labeling and surgical system compatibility requirements.
Clinical Applications
- Primary total hip replacement using a compatible acetabular component and femoral stem.
- Revision total hip replacement when the existing reconstruction is revised with compatible components.
- Ceramic-on-polyethylene or ceramic-on-ceramic hip bearing configurations when specifically permitted by the implant system labeling.
Evidence Summary
The available literature includes 10 studies, ranging from case reports to retrospective analyses, published between 2020 and 2023. These studies evaluate the mechanical properties, wear patterns, and clinical outcomes of the device.
Reported Outcomes
Published studies report that the mectacer biolox forte-femoral heads demonstrate favorable mechanical properties and low wear rates. Long-term follow-up studies indicate successful clinical and radiologic outcomes. However, there are concerns about zirconia phase transformation affecting surface roughness.
Safety Profile
Reported complications include ceramic head fractures, particularly in smaller head sizes and patients with higher body mass indices. Metal transfer and phase transformation of zirconia have also been noted, which may impact the device's mechanical stability.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to fully understand the long-term implications of zirconia phase transformation and its impact on clinical outcomes.
Practical Considerations
- The femoral head must match the compatible femoral stem taper, neck length, diameter, and bearing configuration specified by the implant system.
- Available sizes and offsets depend on the Medacta implant system and the specific product labeling.
- Ceramic components require careful handling; dropping, scratching, or striking the head can increase the risk of damage or fracture.
- MRI safety depends on the complete hip implant construct, including the stem, acetabular component, liners, and any other implanted materials. The full implant system should be evaluated under current MR-conditional labeling.
- Contraindications and precautions include infection, inadequate bone or soft-tissue support, and patient or surgical factors that make total hip arthroplasty unsuitable.
Frequently Asked Questions
What are the clinical indications for mectacer biolox forte-femoral heads?
The device is indicated for use in total hip arthroplasty, particularly for patients requiring durable and low-wear joint replacements.
What outcomes have been reported in clinical studies?
Studies report favorable mechanical properties and low wear rates, with successful clinical and radiologic outcomes over the long term.
What complications have been reported?
Safety data indicate risks of ceramic head fractures, metal transfer, and zirconia phase transformation, which may affect mechanical stability.
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.