đź“Š Evidence-Based Reference
Cormet Hip Resurfacing System
Corin U
Summary: The Cormet Hip Resurfacing System by Corin U is a metal-on-metal hip resurfacing device primarily used in younger, active patients. Key evidence highlights its long-term survivorship and potential complications related to heat generation during preparation.
FDA Clearance Information
Pathway ?
PMA
Number ?
P050016 ↗
Decision Date ?
July 17, 2020
Product Code ?
NXT
Device Class ?
Class 3
Evidence ?
0 studies
The Cormet Hip Resurfacing System received FDA premarket approval (PMA) on July 17, 2020. It is manufactured by Corin U and classified as a Class 3 device under product code NXT.
What It Is
The Cormet Hip Resurfacing System is a metal-on-metal hip resurfacing device designed to preserve femoral bone stock and provide increased range of motion. It is intended for use in younger, active patients as an alternative to total hip arthroplasty.
FDA-Cleared Indications
- FDA-approved labeling was updated to include a summary of results from the completed long-term post-approval study.
- The device is indicated for hip resurfacing arthroplasty in appropriately selected patients according to the approved labeling.
Clinical Applications
- Hip resurfacing arthroplasty as an alternative to total hip arthroplasty in selected patients.
- Treatment of end-stage hip joint disease requiring arthroplasty.
- Treatment planning for appropriately selected younger or active patients when femoral bone preservation is clinically important.
Evidence Summary
The available literature includes a mix of study types such as RCTs, prospective, and retrospective studies, with a total of 8 peer-reviewed studies. The studies span from 2012 to 2022, providing a comprehensive overview of the device's performance.
Reported Outcomes
Published studies report that the Cormet Hip Resurfacing System demonstrates favorable long-term survivorship, with a Kaplan-Meier survivorship of 93% at 11 years. The device is noted for preserving femoral bone stock and providing excellent performance in high-activity patients.
Safety Profile
Reported complications include the potential for heat generation during femoral head preparation, which could exceed temperatures known to cause osteonecrosis. This highlights the importance of careful surgical technique to mitigate such risks.
Evidence Limitations
Evidence gaps include the need for more randomized controlled trials to confirm long-term outcomes and safety. Some studies report confounding factors that may affect the reproducibility of favorable results, indicating areas for further research.
Practical Considerations
- This is a metal-on-metal implant; patients require appropriate clinical follow-up for implant performance and possible metal-related complications.
- The implant is selected in multiple sizes to match patient anatomy; sizing and component positioning are determined during preoperative planning and surgery.
- It is implanted surgically through the hip and requires preparation of the femoral head and acetabulum.
- Patient selection is important. Femoral head or neck bone quality, anatomy, kidney function, allergy history, and conditions that increase fracture or implant-failure risk should be reviewed.
- MRI safety and scanning conditions depend on the current implant labeling and the complete implanted construct. Patients should provide the implant identification information to the MRI facility before scanning.
Frequently Asked Questions
What are the clinical indications for Cormet Hip Resurfacing System?
The device is indicated for use in younger, active patients requiring hip arthroplasty, with a focus on bone preservation and reduced dislocation risk.
What outcomes have been reported in clinical studies?
Studies report a 93% survivorship at 11 years, with benefits including bone preservation and high performance in active patients.
What complications have been reported?
Safety data indicate potential heat generation during preparation, which could lead to osteonecrosis if not managed properly.
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.