đź“‹ FDA Reference
biopro tara femoral resurfacing component
Biopro
Summary: The Biopro Tara Femoral Resurfacing Component is a medical device used in orthopedic surgery for femoral resurfacing. It is primarily utilized by orthopedic surgeons for patients requiring knee joint preservation.
FDA Clearance Information
Pathway
510K
Number
K043542 ↗
Decision Date
May 18, 2005
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
The Biopro Tara Femoral Resurfacing Component was cleared through the FDA 510k pathway on May 18, 2005. Manufactured by Biopro, it is classified as a Class 2 device under product code KXA.
What It Is
The Biopro Tara Femoral Resurfacing Component is an orthopedic implant designed to resurface the femoral component of the knee joint. It is used in procedures aimed at preserving the knee joint by replacing only the damaged surface of the femur, rather than the entire joint. This approach can help maintain more of the patient's natural bone and joint structure, potentially leading to improved outcomes in terms of mobility and pain relief.
Clinical Applications
This device is commonly used in orthopedic settings, particularly in surgeries aimed at treating patients with localized knee joint damage, such as osteoarthritis confined to the femoral condyle. It is suitable for younger, active patients who may benefit from joint preservation techniques. The device is typically used in hospital operating rooms or specialized orthopedic surgical centers.
Indications for Use
The FDA indications suggest that this device is intended for patients with knee joint conditions that require resurfacing of the femoral component. It is particularly beneficial for those with localized cartilage damage or early-stage arthritis, where full joint replacement is not yet necessary.
Practical Considerations
Clinicians should consider the size and compatibility of the device with the patient's anatomy. The procedure requires precise surgical technique to ensure proper fit and alignment. It is important to assess the patient's overall joint health and activity level when considering this device.
Frequently Asked Questions
What is the Biopro Tara Femoral Resurfacing Component used for?
It is used for resurfacing the femoral component of the knee joint in patients with localized damage or early-stage arthritis.
What specialties typically use this device?
Orthopedic surgeons specializing in joint preservation and knee surgeries typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with knee joint conditions requiring femoral resurfacing, particularly those with localized cartilage damage or early-stage arthritis.
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.