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overture orthopaedics patellofemoral system
Overture Resurfacing
Summary: The Overture Orthopaedics Patellofemoral System is a medical device used in orthopedic surgery to address patellofemoral joint issues. It is primarily used by orthopedic surgeons specializing in knee surgeries.
FDA Clearance Information
Pathway
510K
Number
K231253 ↗
Decision Date
July 7, 2023
Product Code
KRR
Device Class
Class 2
Evidence
0 studies
The Overture Orthopaedics Patellofemoral System was cleared through the FDA 510k pathway on July 7, 2023. It is manufactured by Overture Resurfacing and classified as a Class 2 device.
What It Is
The Overture Orthopaedics Patellofemoral System is an implant designed for the resurfacing of the patellofemoral joint, which is part of the knee. It aims to alleviate pain and restore function in patients with patellofemoral arthritis or other degenerative conditions. The system typically includes components that replace or support the patella and the femoral trochlea, allowing for smoother articulation and reduced joint stress.
Clinical Applications
This device is commonly used in orthopedic procedures for patients suffering from isolated patellofemoral arthritis or chondromalacia. It is particularly beneficial for younger, active patients who require joint preservation rather than total knee replacement. The device is typically used in hospital or surgical center settings by orthopedic surgeons specializing in knee surgeries.
Indications for Use
The FDA-cleared indications suggest that this device is intended for patients with patellofemoral joint degeneration, such as arthritis, where conservative treatments have failed. It is suitable for patients experiencing pain and reduced mobility due to these conditions.
Practical Considerations
The device comes in various sizes to accommodate different patient anatomies and is compatible with standard surgical instruments used in knee arthroplasty. Surgeons should be familiar with the specific implantation technique to ensure optimal outcomes.
Frequently Asked Questions
What is the Overture Orthopaedics Patellofemoral System used for?
It is used for resurfacing the patellofemoral joint in patients with arthritis or degenerative conditions to alleviate pain and improve function.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in knee surgeries, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with patellofemoral joint degeneration, such as arthritis, where conservative treatments have failed.
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.