đź“Š Evidence-Based Reference
New Jersey Femoral Resurfacing Component
Endomedics
Summary: The New Jersey Femoral Resurfacing Component by Endomedics is a Class 2 device cleared by the FDA for femoral resurfacing. Key evidence includes studies on patellar kinematics and hip resurfacing techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K842233 ↗
Decision Date ?
July 20, 1984
Product Code ?
KXA
Device Class ?
Class 2
Evidence ?
0 studies
The New Jersey Femoral Resurfacing Component was cleared via the FDA 510k pathway on July 20, 1984. It is manufactured by Endomedics and classified as a Class 2 device.
What It Is
The New Jersey Femoral Resurfacing Component is designed for femoral resurfacing procedures, primarily used in orthopedic surgeries to restore joint function. It is intended to improve joint kinematics and reduce pain.
FDA-Cleared Indications
- Femoral resurfacing in orthopedic surgery.
- Treatment of damaged or degenerated femoral joint surfaces when resurfacing is indicated.
Clinical Applications
- Femoral resurfacing for selected degenerative joint disease.
- Femoral resurfacing for structural damage involving the joint surface.
- Replacement or capping of the affected femoral surface during joint-resurfacing surgery.
Evidence Summary
The available literature includes three studies ranging from 2004 to 2022, comprising prospective and retrospective analyses. These studies focus on patellar resurfacing effects and hip resurfacing evaluation techniques.
Reported Outcomes
Published studies report that patellar resurfacing can influence patellar kinematics, potentially leading to improvements or deteriorations in joint movement. Hip resurfacing evaluations highlight the need for specific radiographic techniques due to the unique design of the components.
Safety Profile
Reported complications include the need for precise radiographic evaluation techniques to ensure proper placement and function of the resurfacing components. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed outcomes and safety data. Further research is needed to fully understand the long-term efficacy and safety of the device.
Practical Considerations
- Implant size and fit must be selected from the manufacturer’s available component range using preoperative imaging and intraoperative assessment.
- The component must be used with compatible instruments and any specified companion components according to the manufacturer’s labeling.
- Implantation requires orthopedic surgical exposure, sterile handling, and appropriate fixation technique.
- Contraindications and precautions may include active infection, inadequate bone stock, severe deformity, or medical conditions that make joint-replacement surgery unsafe.
- MRI safety and conditional-use information should be confirmed from the device labeling; the available record does not establish MRI conditions.
Frequently Asked Questions
What are the clinical indications for New Jersey Femoral Resurfacing Component?
The device is indicated for use in femoral resurfacing procedures to improve joint function and reduce pain in patients with joint degeneration.
What outcomes have been reported in clinical studies?
Studies have reported changes in patellar kinematics and the need for specific radiographic techniques for hip resurfacing evaluations.
What complications have been reported?
Safety data highlights the importance of accurate radiographic evaluations, though specific adverse events were not detailed in the studies.
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.