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conserve femoral resurfacing component
Wrightmedicaltechnology
Summary: The Conserve Femoral Resurfacing Component is a hip resurfacing device primarily used for patients with osteonecrosis. Key evidence highlights its function, implant survivorship, and bone conservation.
FDA Clearance Information
Pathway
510K
Number
K062960 ↗
Decision Date
December 1, 2006
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
The Conserve Femoral Resurfacing Component was cleared by the FDA via the 510(k) pathway on December 1, 2006. It is manufactured by Wrightmedicaltechnology and is classified as a Class 2 device.
What It Is
The Conserve Femoral Resurfacing Component is a medical device used in hip resurfacing arthroplasty. It is designed to conserve bone and improve joint biomechanics, particularly in patients with osteonecrosis of the femoral head.
Clinical Applications
This device is commonly used in hip resurfacing procedures for patients with osteonecrosis or poor femoral head bone quality. It serves as an alternative to total hip arthroplasty, especially in younger, active patients.
Evidence Summary
The available literature includes 13 studies, comprising various study types such as RCTs, prospective, and retrospective studies, published between 2015 and 2019. These studies evaluate outcomes like implant survivorship and complications.
Reported Outcomes
Published studies report that the Conserve Femoral Resurfacing Component demonstrates good implant survivorship and function. It is associated with acetabular bone conservation and improved joint biomechanics. However, some studies highlight the occurrence of femoral neck narrowing over time.
Safety Profile
Reported complications include femoral neck osteolysis and narrowing, which may lead to fractures. These issues are particularly noted in patients with poor bone quality or abnormal femoral head morphology.
Evidence Limitations
The evidence is limited by the lack of long-term follow-up data and small sample sizes in some studies. Further research is needed to assess the long-term safety and efficacy of the device, particularly in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Conserve Femoral Resurfacing Component?
The device is indicated for hip resurfacing in patients with osteonecrosis or poor femoral head bone quality, serving as an alternative to total hip arthroplasty.
What outcomes have been reported in clinical studies?
Studies report good implant survivorship, function, and acetabular bone conservation, with some concerns about femoral neck narrowing.
What complications have been reported?
Safety data indicate complications such as femoral neck osteolysis and narrowing, potentially leading to fractures.
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.