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recap ha press-fit femoral resurfacing head
Biomet
Summary: The recap ha press-fit femoral resurfacing head is a medical device used in orthopedic procedures to resurface the femoral head. It is primarily utilized by orthopedic surgeons in hip joint surgeries.
FDA Clearance Information
Pathway
510K
Number
K071053 ↗
Decision Date
June 29, 2007
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
The recap ha press-fit femoral resurfacing head was cleared through the FDA 510k pathway on June 29, 2007. Manufactured by Biomet, it is classified as a Class 2 device under product code KXA.
What It Is
The recap ha press-fit femoral resurfacing head is an orthopedic implant designed to resurface the femoral head in hip joint surgeries. It is made from materials that promote bone integration and is designed to fit securely without the need for cement. This device helps restore joint function and alleviate pain in patients with hip joint degeneration.
Clinical Applications
This device is commonly used in hip resurfacing procedures, which are an alternative to total hip replacement. It is particularly suitable for younger, active patients with osteoarthritis or other degenerative hip conditions. Orthopedic surgeons use it in hospital or surgical center settings to preserve more of the patient's natural bone structure while providing pain relief and improved mobility.
Indications for Use
The FDA indications suggest this device is intended for patients requiring hip joint resurfacing due to conditions like osteoarthritis. It is suitable for those who are candidates for hip replacement but may benefit from a bone-preserving alternative.
Practical Considerations
The recap ha press-fit femoral resurfacing head comes in various sizes to accommodate different patient anatomies. It requires precise surgical technique for optimal placement and stability. Compatibility with other hip joint components should be verified during pre-surgical planning.
Frequently Asked Questions
What is recap ha press-fit femoral resurfacing head used for?
It is used for resurfacing the femoral head in hip joint surgeries, particularly in patients with hip degeneration.
What specialties typically use this device?
Orthopedic surgeons typically use this device in hip resurfacing procedures.
What are the FDA-cleared indications?
It is indicated for patients needing hip joint resurfacing due to degenerative conditions like osteoarthritis.
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.