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hemicap patello-femoral resurfacing prosthesis
Arthrosurface
Summary: The HemiCAP Patello-Femoral Resurfacing Prosthesis is used for treating patellofemoral joint osteoarthritis. It is typically used by orthopedic surgeons to improve joint function and reduce pain in affected patients.
FDA Clearance Information
Pathway
510K
Number
K060127 ↗
Decision Date
March 16, 2006
Product Code
KRR
Device Class
Class 2
Evidence
0 studies
The HemiCAP Patello-Femoral Resurfacing Prosthesis was cleared via the 510k pathway on March 16, 2006. Manufactured by Arthrosurface, it is a Class 2 medical device.
What It Is
The HemiCAP Patello-Femoral Resurfacing Prosthesis is a surgical implant designed to resurface the patellofemoral joint, which is part of the knee. It is used to treat osteoarthritis by providing a smooth, contoured surface that mimics the natural anatomy of the joint. This device helps reduce pain and improve mobility by replacing damaged cartilage with a metal cap that fits precisely onto the femur and patella.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly in patients with isolated patellofemoral osteoarthritis. It is suitable for patients who have not responded to conservative treatments and are not candidates for total knee replacement. The procedure is often performed in hospital surgical settings, and the typical patient population includes middle-aged to older adults, especially women, who experience significant knee pain and functional impairment.
Indications for Use
The FDA indications for this device include treatment of patellofemoral joint osteoarthritis. It is intended for patients with localized cartilage damage in the knee, particularly those who experience pain and limited mobility due to the degeneration of the joint surface.
Practical Considerations
The HemiCAP system offers various sizing options to accommodate different anatomical variations. It is important for surgeons to ensure proper alignment and fit during implantation to maximize the functional outcome. Compatibility with existing surgical instruments and techniques is generally straightforward, but precise surgical technique is crucial for optimal results.
Related Literature
The linked study from 2019 evaluated the clinical and functional outcomes of patellofemoral resurfacing arthroplasties. It highlighted the effectiveness of anatomical and biomechanically appropriate systems in treating patellofemoral osteoarthritis, particularly in women. The study found improved functional results and earlier intervention stages. However, limitations included a focus on a specific patient demographic and the need for longer-term follow-up data.
Frequently Asked Questions
What is the HemiCAP Patello-Femoral Resurfacing Prosthesis used for?
It is used to treat osteoarthritis of the patellofemoral joint by resurfacing the damaged area to reduce pain and improve joint function.
What specialties typically use this device?
Orthopedic surgeons specializing in knee surgery and joint preservation commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the treatment of patellofemoral joint osteoarthritis, particularly in patients with localized cartilage damage.
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.