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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
510K
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.
Clinical Applications
This device is commonly used in orthopedic surgeries involving femoral resurfacing, particularly in cases of joint degeneration or damage. It is utilized to enhance joint mobility and alleviate pain in affected patients.
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.
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.