đź“Š Evidence-Based Reference
modified new jersey femoral hip resurfacing compon
Endotec
Summary: The modified New Jersey femoral hip resurfacing component by Endotec is a Class 2 medical device cleared by the FDA for hip resurfacing. It is primarily used in orthopedic procedures to address hip joint issues. Key evidence highlights its role in reducing early postoperative complications.
FDA Clearance Information
Pathway
510K
Number
K904870 ↗
Decision Date
May 23, 1991
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on May 23, 1991. It is manufactured by Endotec and classified as a Class 2 device under product code KXA.
What It Is
The modified New Jersey femoral hip resurfacing component is designed for hip resurfacing procedures. It aims to preserve the femoral head while providing a stable joint surface, thus reducing the need for total hip replacement.
Clinical Applications
This device is commonly used in patients requiring hip resurfacing, particularly those with osteoarthritis or avascular necrosis of the hip. It is suitable for patients who are not ideal candidates for total hip arthroplasty.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective, and retrospective studies. The studies span from 2016 to 2022, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the device is effective in reducing early postoperative periprosthetic fractures and improving patient-reported outcomes over a minimum of two years. The device has shown promising results in maintaining joint stability and function.
Safety Profile
Reported complications include early postoperative periprosthetic fractures and potential iatrogenic hip instability. However, the overall safety profile is consistent with similar orthopedic devices.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to establish the long-term efficacy and safety of the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for modified new jersey femoral hip resurfacing compon?
The device is indicated for hip resurfacing in patients with osteoarthritis or avascular necrosis, particularly those who are not candidates for total hip replacement.
What outcomes have been reported in clinical studies?
Clinical studies have reported reduced early postoperative periprosthetic fractures and improved patient-reported outcomes over a minimum of two years.
What complications have been reported?
Reported complications include early postoperative periprosthetic fractures and potential iatrogenic hip instability.
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.