📊 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 ?
510(k)
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.
FDA-Cleared Indications
- Use in femoral hip resurfacing procedures.
- Use as a femoral component to provide an articulating surface in the hip joint.
Clinical Applications
- Femoral head resurfacing during hip arthroplasty.
- Treatment of hip joint disease requiring replacement or resurfacing of the femoral articular surface.
- Use with a compatible acetabular component when performing hip resurfacing 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.
Practical Considerations
- The implant is intended for use with compatible components selected by the orthopedic surgeon; sizing and fit depend on the patient's femoral head and hip anatomy.
- Hip resurfacing requires surgical exposure of the hip and preparation of the femoral head rather than removal of the entire femoral head and neck.
- The FDA record provided does not specify MRI safety conditions, implant materials, available sizes, or compatibility with other components; consult the device labeling and implant documentation.
- Contraindications and patient selection factors may include inadequate femoral bone quality, severe femoral head damage, infection, or other conditions identified in the manufacturer's labeling and by the treating surgeon.
- Hip resurfacing may not be appropriate for every patient; alternatives can include medication, other joint-preserving treatment, or total hip arthroplasty.
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.