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 ?
510(k)
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.
FDA-Cleared Indications
- Use for femoral head resurfacing in patients with degenerative disease of the hip joint.
- Use as a contoured prosthetic cap over the prepared femoral head to restore the articular surface.
Clinical Applications
- Femoral head resurfacing during hip-preservation surgery.
- Treatment of selected hip joint degeneration when the femoral head can be surgically preserved.
- Use of a size-matched prosthetic cap to replace the damaged articular surface of the femoral head.
Practical Considerations
- The implant is available in different sizes; the surgeon selects the size based on femoral head anatomy and operative measurements.
- Implantation requires precise preparation of the femoral head and familiarity with the applicable surgical technique.
- Compatibility with the manufacturer’s instruments and any other implants used during surgery should be confirmed before the procedure.
- MRI safety depends on the implant materials and the specific labeling available for the implanted model; the operative implant record should be reviewed before MRI.
- Patient selection, including bone quality, femoral head anatomy, infection risk and the extent of joint damage, is determined by the orthopedic surgeon.
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.