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biocore9 femoral head resurfacing component
Biocore9
Summary: The biocore9 femoral head resurfacing component is a device used for hip resurfacing, primarily in young and active patients to preserve femoral bone stock. Key evidence highlights concerns about metal-on-metal bearings and associated adverse reactions.
FDA Clearance Information
Pathway
510K
Number
K201219 ↗
Decision Date
January 19, 2021
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
The biocore9 femoral head resurfacing component was cleared through the FDA 510k pathway on January 19, 2021. It is manufactured by Biocore9 and classified as a Class 2 device.
What It Is
The biocore9 femoral head resurfacing component is designed for hip resurfacing procedures, aiming to preserve femoral bone stock in patients. It is intended for use in young and active individuals who require hip joint restoration.
Clinical Applications
This device is commonly used in patients with osteonecrosis of the femoral head or those who have failed previous hip interventions. It is particularly suited for individuals with good bone quality who are at risk of traditional total hip arthroplasty failure.
Evidence Summary
The available literature includes a mix of RCTs, prospective, retrospective, and case series studies, with a total of 10 studies ranging from 2012 to 2023. These studies explore various aspects of hip resurfacing, including outcomes and safety.
Reported Outcomes
Published studies report that hip resurfacing with the biocore9 component can preserve femoral bone stock and improve joint function in young, active patients. However, there are concerns about the long-term performance of metal-on-metal bearings, with some studies noting frequent femoral neck osteolysis.
Safety Profile
Reported complications include adverse reactions to metal debris, which have led to a decline in the use of metal-on-metal hip resurfacing devices. Other studies highlight the risk of femoral neck osteolysis and the need for careful patient selection.
Evidence Limitations
The evidence is limited by a lack of long-term follow-up data and variability in study designs. Further research is needed to assess the long-term safety and efficacy of the biocore9 component, particularly concerning metal-on-metal bearing surfaces.
Frequently Asked Questions
What are the clinical indications for biocore9 femoral head resurfacing component?
The device is indicated for hip resurfacing in young, active patients, particularly those with osteonecrosis of the femoral head or previous hip intervention failures.
What outcomes have been reported in clinical studies?
Studies report improved joint function and femoral bone stock preservation, but also note concerns about metal-on-metal bearing performance and femoral neck osteolysis.
What complications have been reported?
Safety data indicate adverse reactions to metal debris and femoral neck osteolysis as significant complications associated with the device.
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.