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uni knee resurfacing system
Overture Resurfacing
Summary: The Uni Knee Resurfacing System by Overture Resurfacing is a device cleared for resurfacing procedures in knee joints. It is primarily used for treating knee osteoarthritis. Key evidence includes studies on patient-specific implants and care pathways.
FDA Clearance Information
Pathway
510K
Number
K221292 ↗
Decision Date
March 10, 2023
Product Code
HSX
Device Class
Class 2
Evidence
0 studies
The Uni Knee Resurfacing System was cleared by the FDA via the 510(k) pathway on March 10, 2023. It is manufactured by Overture Resurfacing and classified as a Class 2 device.
What It Is
The Uni Knee Resurfacing System is designed for resurfacing the knee joint, particularly in cases of osteoarthritis. It aims to preserve joint function by resurfacing damaged areas without the need for total knee replacement.
Clinical Applications
Commonly used in patients with knee osteoarthritis, the device is applied in scenarios where joint preservation is preferred over total knee arthroplasty. It is suitable for patients with localized cartilage damage.
Evidence Summary
The literature includes five studies ranging from 2005 to 2025, covering various aspects of knee resurfacing and related procedures. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report mixed outcomes regarding patient satisfaction and functional improvement. Some studies highlight the benefits of patient-specific implants, while others focus on the perceptions of care pathways in knee osteoarthritis treatment.
Safety Profile
Reported complications include issues related to implant fit and alignment, as well as general surgical risks such as infection and thrombosis. Specific safety data from the studies is limited.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of long-term outcome data. Further research is needed to establish standardized protocols and assess long-term efficacy and safety.
Frequently Asked Questions
What are the clinical indications for uni knee resurfacing system?
The device is indicated for resurfacing procedures in patients with knee osteoarthritis, particularly when joint preservation is desired.
What outcomes have been reported in clinical studies?
Studies report mixed outcomes, with some indicating improved patient satisfaction and functional outcomes, while others focus on the challenges of care pathways.
What complications have been reported?
Reported complications include implant fit issues, alignment problems, and general surgical risks such as infection and thrombosis.
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.