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surface replacement hip prosthesis
Biomet
Summary: The surface replacement hip prosthesis by Biomet is a device used for hip joint replacement. It is primarily used in cases of severe hip damage. Key evidence highlights its wear prediction and survivorship challenges.
FDA Clearance Information
Pathway
510K
Number
K811718 ↗
Decision Date
September 18, 1981
Product Code
KYB
Device Class
Class 1
Evidence
0 studies
The surface replacement hip prosthesis was cleared by the FDA through the 510k pathway on September 18, 1981. It is manufactured by Biomet and classified as a Class 1 device.
What It Is
The surface replacement hip prosthesis is a medical device designed to replace the surface of the hip joint. It is used in patients with severe hip joint damage to restore mobility and alleviate pain.
Clinical Applications
This device is commonly used in patients with osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the hip. It is also considered for younger patients with high activity levels requiring joint replacement.
Evidence Summary
The literature includes 15 studies ranging from 2018 to 2023, encompassing various study types such as RCTs, retrospective reviews, and computational analyses. These studies explore wear prediction, survivorship, and bearing surface options.
Reported Outcomes
Published studies report that metal-on-highly cross-linked polyethylene surfaces show favorable outcomes in the first 10 to 15 years. However, the articular surface replacement components have shown higher early failure rates, necessitating careful patient selection.
Safety Profile
Reported complications include wear-related failures and early device failure in certain metal-on-metal configurations. These findings highlight the importance of monitoring and selecting appropriate bearing surfaces.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of long-term data on newer surface technologies. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for surface replacement hip prosthesis?
The device is indicated for patients with severe hip joint damage due to conditions like osteoarthritis or rheumatoid arthritis.
What outcomes have been reported in clinical studies?
Studies report favorable outcomes with metal-on-highly cross-linked polyethylene surfaces, but higher failure rates with certain metal-on-metal components.
What complications have been reported?
Safety data indicate wear-related failures and early device failure in some configurations, particularly metal-on-metal surfaces.
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.