đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Resurfacing of the patellofemoral compartment of the knee in patients with patellofemoral joint disease, as specified in the FDA-cleared labeling.
Clinical Applications
- Patellofemoral arthroplasty for isolated disease of the patellofemoral compartment
- Replacement or resurfacing of the diseased femoral trochlear surface
- Replacement or resurfacing of the diseased patellar surface
- Use during knee surgery when the patellofemoral compartment requires treatment without replacing the entire knee joint
Practical Considerations
- The system is supplied in multiple sizes to match patient anatomy; implant selection is based on preoperative imaging and intraoperative assessment.
- Implantation requires the manufacturer’s instrumentation and surgical technique, performed by an orthopedic surgeon familiar with patellofemoral arthroplasty.
- The device is intended for the patellofemoral compartment and is not a total knee replacement; disease in other knee compartments may affect patient selection.
- MRI safety and conditional scanning requirements should be confirmed in the current manufacturer’s labeling and implant documentation before MRI.
- Contraindications and precautions include conditions that compromise fixation, bone quality, soft-tissue stability, or the ability to follow postoperative care; the full FDA-cleared labeling should be reviewed.
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.