📋 FDA Reference
Mectacer Biolox R Delta Femoral Heads
Medacta International
Summary: The Mectacer BIOLOX R Delta Femoral Heads are ceramic components used in hip replacement surgeries to reduce wear and improve joint longevity. They are primarily used by orthopedic surgeons in total hip arthroplasty procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K112115 ↗
Decision Date ?
October 7, 2011
Product Code ?
LZO
Device Class ?
Class 2
Evidence ?
0 studies
The Mectacer BIOLOX R Delta Femoral Heads were cleared through the FDA 510(k) pathway on October 7, 2011. Manufactured by Medacta International, this device is classified as a Class 2 medical device under product code LZO.
What It Is
The Mectacer BIOLOX R Delta Femoral Heads are advanced ceramic components used in total hip replacements. These femoral heads are made from BIOLOX delta, a high-strength ceramic material known for its durability and low wear characteristics. The ceramic-on-ceramic articulation provides a smooth surface that minimizes friction and wear, which is crucial for the longevity of the implant and the reduction of osteolysis caused by wear particles.
FDA-Cleared Indications
- Use in total hip arthroplasty for patients who require replacement of the femoral head and acetabular joint surfaces because of degenerative or traumatic joint disease.
- Use with compatible Medacta hip system components according to the applicable device labeling and surgical technique.
Clinical Applications
- Ceramic femoral-head replacement during primary total hip arthroplasty.
- Treatment of end-stage hip joint disease when total hip replacement is indicated.
- Use with a compatible acetabular component as part of a total hip implant system.
- Reconstruction of the femoral side of the hip joint using an appropriately sized ceramic head.
Practical Considerations
- The femoral head must be matched to a compatible femoral stem taper, acetabular component, head diameter, and neck length listed in the applicable labeling.
- Available sizes and configurations should be selected to restore hip biomechanics and accommodate the patient's anatomy.
- Ceramic components require careful handling; scratching, contamination, improper assembly, or damage to the taper can increase the risk of fracture or implant failure.
- The implant is intended for use by orthopedic surgeons familiar with total hip arthroplasty and the relevant surgical technique.
- MRI safety depends on the complete hip implant system and its metallic components. The specific implant labeling and current MRI conditions should be reviewed before scanning.
Related Literature
The linked study investigated the wear characteristics of 36-mm BIOLOX delta ceramic-on-ceramic bearings under edge loading conditions, which simulate clinical scenarios of malpositioning. The study found that increasing head size could influence wear rates, highlighting the importance of proper surgical technique. However, the study was limited by its focus on a specific head size and laboratory conditions, which may not fully replicate in vivo environments.
Frequently Asked Questions
What is Mectacer BIOLOX R Delta Femoral Heads used for?
They are used in total hip replacement surgeries to provide a durable, low-wear articulation surface.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and hip arthroplasty use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients needing hip replacement due to degenerative joint diseases like osteoarthritis and rheumatoid arthritis.
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.