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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 ?
510(k)
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.
FDA-Cleared Indications
- Hip resurfacing arthroplasty in patients with degenerative or traumatic arthritis involving the hip joint.
- Hip resurfacing in patients with osteonecrosis of the femoral head.
- Hip resurfacing in patients with femoral-head deformity or loss of bone stock that can be treated with a resurfacing component.
- Use as a component of a hip replacement system when the femoral head and acetabular joint surface require reconstruction.
Clinical Applications
- Femoral-side reconstruction during metal-on-metal hip resurfacing arthroplasty.
- Treatment of symptomatic osteonecrosis of the femoral head when the remaining femoral head and neck can support resurfacing.
- Treatment of selected degenerative hip arthritis or post-traumatic hip-joint damage.
- Use with a compatible acetabular resurfacing component as part of a complete hip resurfacing system.
Reported off-label uses
- Use in selected younger or highly active patients with other causes of end-stage hip arthritis may be described in clinical practice, but patient selection must follow the device labeling and the treating surgeon's judgment.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The component is selected by femoral-head and femoral-neck anatomy; available sizes and instrumentation should be confirmed in the current manufacturer’s surgical technique and sizing system.
- It is intended for use with compatible components from the corresponding hip resurfacing system. Mixing components from different systems may be contraindicated unless specifically permitted by labeling.
- Metal-on-metal hip resurfacing requires patient selection and follow-up because metal wear debris, elevated blood metal-ion levels, adverse local tissue reactions, and implant loosening are recognized concerns.
- Contraindications may include inadequate femoral bone stock, severe femoral-head or neck deformity, infection, substantial renal impairment, metal hypersensitivity, and conditions that prevent reliable postoperative follow-up; the current labeling controls.
- MRI safety depends on the complete implanted system and the conditions specified by the manufacturer. The exact implant model and MRI instructions should be confirmed before scanning.
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.