📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Treatment of cartilage damage involving the patellofemoral compartment of the knee.
- Use in patients with localized cartilage lesions or degenerative changes affecting the patellofemoral joint.
Clinical Applications
- Focal resurfacing of a damaged area on the patella or femoral trochlea.
- Treatment of symptomatic patellofemoral cartilage defects when conservative treatment has not provided adequate relief.
- Use during partial knee joint resurfacing rather than total knee replacement in appropriately selected patients.
- Treatment of localized patellofemoral degeneration in patients with preserved, otherwise suitable knee compartments.
Practical Considerations
- The implant is available in multiple sizes and is selected to match the patient's anatomy and the size and location of the cartilage defect.
- Implantation is performed by an orthopedic surgeon using open or minimally invasive knee-surgery techniques, with imaging and instruments selected according to the surgical system.
- Patient selection is important; advanced arthritis involving multiple knee compartments, infection, inadequate bone stock, or other contraindications may make this type of resurfacing unsuitable.
- MRI safety and artifact information depend on the exact implant materials and labeling; the operative implant record and current manufacturer MRI instructions should be reviewed before scanning.
- The expected durability depends on patient age, activity, alignment, bone and cartilage condition, and progression of arthritis. The device does not prevent degeneration elsewhere in the knee.
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.