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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.
Clinical Applications
This device is commonly used in clinical scenarios involving younger patients who require hip arthroplasty but wish to maintain a high level of physical activity. It is particularly suited for patients who may benefit from bone preservation and reduced dislocation risk.
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.
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.