đź“Š Evidence-Based Reference
resurface prostheses for hip joint
Holco Instrument
Summary: Resurface prostheses for the hip joint by Holco Instrument are used primarily for hip resurfacing procedures. Key evidence highlights the risk of complications such as elevated metal ion levels and adverse local tissue reactions.
FDA Clearance Information
Pathway
510K
Number
K761324 ↗
Decision Date
January 5, 1977
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
The resurface prostheses for hip joint by Holco Instrument were cleared via the FDA 510(k) pathway on January 5, 1977. It is classified as a Class 2 device under product code KXA.
What It Is
The resurface prostheses for the hip joint are designed to replace the surface of the femoral head while preserving more of the patient's natural bone. It is intended for use in patients requiring hip resurfacing due to conditions like osteoarthritis.
Clinical Applications
Commonly used in younger, active patients with hip disease who require pain relief and functional restoration. It is particularly useful when the femoral canal is blocked, making total hip arthroplasty difficult.
Evidence Summary
The literature includes 12 studies ranging from 2016 to 2025, encompassing various study types such as RCTs and retrospective analyses. These studies provide insights into the outcomes and safety of hip resurfacing.
Reported Outcomes
Published studies report that hip resurfacing can relieve pain and restore function in patients with hip disease. However, outcomes vary, with some studies noting the need for revision to total hip arthroplasty in cases of aseptic failure.
Safety Profile
Reported complications include elevated metal ion levels and adverse local tissue reactions, such as pseudotumors. Female patients and those with smaller femoral heads may be at higher risk.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of long-term follow-up data. Further research is needed to better understand the long-term safety and efficacy of hip resurfacing, particularly in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for resurface prostheses for hip joint?
Indicated for patients requiring hip resurfacing due to conditions like osteoarthritis, particularly when the femoral canal is blocked.
What outcomes have been reported in clinical studies?
Studies report pain relief and functional restoration, with some cases requiring revision to total hip arthroplasty.
What complications have been reported?
Safety data indicate risks of elevated metal ion levels and adverse local tissue reactions, such as pseudotumors.
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.