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hemicap patello-femoral resurfacing system
Arthrosurface
Summary: The HemiCAP Patello-Femoral Resurfacing System is a medical device used for the treatment of 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
K071413 ↗
Decision Date
November 9, 2007
Product Code
KRR
Device Class
Class 2
Evidence
0 studies
The HemiCAP Patello-Femoral Resurfacing System was cleared through the FDA 510(k) pathway on November 9, 2007. Manufactured by Arthrosurface, it is classified as a Class 2 device under product code KRR.
What It Is
The HemiCAP Patello-Femoral Resurfacing System is designed to address cartilage damage in the patellofemoral joint by providing a contoured implant that matches the patient's anatomy. It aims to restore the joint surface, reduce pain, and improve mobility. The system is particularly useful for patients with localized cartilage lesions or early-stage osteoarthritis.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly in procedures involving the knee joint. It is suitable for patients experiencing anterior knee pain due to cartilage damage or degeneration. The device is typically used in outpatient surgical settings and is often chosen for younger, active patients who are not yet candidates for total knee replacement.
Indications for Use
The FDA indications for the HemiCAP Patello-Femoral Resurfacing System include treatment of cartilage damage in the patellofemoral joint. It is intended for patients with localized cartilage lesions or early-stage osteoarthritis, particularly those who have not responded to conservative treatments.
Practical Considerations
The system offers various sizing options to accommodate different patient anatomies, ensuring a precise fit. Surgeons should be familiar with arthroscopic techniques and have experience in knee surgeries to optimize outcomes. Compatibility with existing surgical instruments is generally good, but verification is recommended.
Related Literature
The linked study 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 in earlier stages of the condition, though it was limited by its focus on a specific patient demographic.
Frequently Asked Questions
What is the HemiCAP Patello-Femoral Resurfacing System used for?
It is used to treat cartilage damage in the patellofemoral joint, often due to osteoarthritis or localized cartilage lesions.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in knee surgeries, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for treating cartilage damage in the patellofemoral joint, especially in patients with early-stage osteoarthritis or localized cartilage lesions.
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.