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prosthesis patellar articular surface
Depuy
Summary: The prosthesis patellar articular surface by Depuy is designed for knee arthroplasty procedures. It is primarily used to improve patellar tracking and reduce pain. Key evidence suggests no significant advantage in patellar resurfacing with modern knee arthroplasty designs.
FDA Clearance Information
Pathway
510K
Number
K760200 ↗
Decision Date
July 20, 1976
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on July 20, 1976. It is manufactured by Depuy and classified as a Class 2 medical device under product code JWH.
What It Is
The prosthesis patellar articular surface is a component used in knee arthroplasty to replace or resurface the patellar surface. It aims to enhance joint function and reduce pain by providing a smooth articulating surface for the patella.
Clinical Applications
Commonly used in total knee arthroplasty, this device is indicated for patients requiring patellar resurfacing due to degenerative joint disease or other knee pathologies. It is particularly relevant in cases where patellar tracking and alignment are compromised.
Evidence Summary
The literature includes 15 studies, with types ranging from randomized controlled trials to systematic reviews. The studies span from 2003 to 2024, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that modern total knee arthroplasty designs, which include the prosthesis patellar articular surface, do not show a clinically significant advantage in patellar resurfacing. The outcomes suggest that both resurfaced and non-resurfaced patellas perform similarly in terms of pain relief and joint function.
Safety Profile
Reported complications include potential undermining of patellar vascularization and integrity of the extensor apparatus during surgical approaches. However, specific adverse events related to the device itself are not extensively documented in the provided evidence.
Evidence Limitations
The evidence lacks detailed safety data specific to the prosthesis patellar articular surface. Further research is needed to explore long-term outcomes and potential complications associated with the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for prosthesis patellar articular surface?
The device is indicated for use in total knee arthroplasty procedures, particularly for patients requiring patellar resurfacing due to degenerative joint disease.
What outcomes have been reported in clinical studies?
Studies indicate no significant advantage in patellar resurfacing with modern knee arthroplasty designs, suggesting similar outcomes for resurfaced and non-resurfaced patellas.
What complications have been reported?
Reported complications include potential issues with patellar vascularization and extensor apparatus integrity during surgical approaches, though specific device-related adverse events are not well-documented.
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.