đź“‹ FDA Reference
contoured articular prosthesis cap femoral head resurfacing system
Std Mfg.
Summary: The contoured articular prosthesis cap is a femoral head resurfacing system used primarily in orthopedic procedures to treat joint degeneration. It is typically utilized by orthopedic surgeons in hospitals and surgical centers.
FDA Clearance Information
Pathway
510K
Number
K021549 ↗
Decision Date
August 1, 2002
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
This device was cleared via the FDA 510k pathway on August 1, 2002. Manufactured by Std Mfg., it is classified as a Class 2 device under product code KXA.
What It Is
The contoured articular prosthesis cap is a medical device designed for femoral head resurfacing, a procedure that aims to restore joint function by covering the femoral head with a prosthetic cap. This device helps to alleviate pain and improve mobility in patients with joint degeneration, such as osteoarthritis. The prosthesis is contoured to fit the natural shape of the femoral head, providing a less invasive alternative to total hip replacement.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly for patients with degenerative joint diseases like osteoarthritis or avascular necrosis. It is suitable for younger, active patients who may benefit from joint preservation rather than total joint replacement. The procedure is typically performed in hospital settings by orthopedic surgeons specializing in joint preservation and reconstruction.
Indications for Use
The FDA-cleared indications for this device include use in patients with degenerative joint conditions affecting the hip, where joint resurfacing is deemed appropriate. It is intended for individuals who require pain relief and improved joint function but are not candidates for total hip replacement.
Practical Considerations
The prosthesis comes in various sizes to accommodate different patient anatomies, ensuring a proper fit. Surgeons should be familiar with the specific surgical technique required for implantation, which involves precise preparation of the femoral head. Compatibility with existing surgical instruments and systems should be verified prior to use.
Frequently Asked Questions
What is the contoured articular prosthesis cap used for?
It is used for resurfacing the femoral head in patients with joint degeneration to alleviate pain and improve mobility.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in joint preservation and reconstruction, commonly use this device.
What are the FDA-cleared indications?
It is indicated for patients with degenerative joint conditions affecting the hip, suitable for joint resurfacing rather than total hip replacement.
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.