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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
510K
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.
Clinical Applications
These femoral heads are commonly used in total hip arthroplasty, particularly in younger, more active patients who require durable and long-lasting joint replacements. Orthopedic surgeons in both hospital and specialized orthopedic centers frequently use these components. The device is suitable for patients with degenerative joint diseases such as osteoarthritis, rheumatoid arthritis, or avascular necrosis.
Indications for Use
The FDA indications suggest that the Mectacer BIOLOX R Delta Femoral Heads are intended for use in patients requiring total hip replacement due to joint degeneration. This includes conditions like osteoarthritis, rheumatoid arthritis, and other degenerative joint diseases.
Practical Considerations
The Mectacer BIOLOX R Delta Femoral Heads come in various sizes to accommodate different patient anatomies. They are compatible with a range of acetabular components, but it is essential to ensure proper alignment and positioning to prevent edge loading and increase longevity. Surgeons should be familiar with ceramic handling techniques to avoid intraoperative fractures.
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.