đź“‹ FDA Reference
contoured articular prosthesis cap humeral head resurfacing system
Std Mfg.
Summary: The contoured articular prosthesis cap humeral head resurfacing system is a medical device used for joint resurfacing in the shoulder. It is primarily used by orthopedic surgeons to restore joint function in patients with joint defects.
FDA Clearance Information
Pathway
510K
Number
K023096 ↗
Decision Date
April 10, 2003
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on April 10, 2003. It is manufactured by Std Mfg. and classified as a Class 2 device under product code HSD.
What It Is
The contoured articular prosthesis cap humeral head resurfacing system is designed to resurface the humeral head in the shoulder joint. It provides an anatomical fit to replace damaged articular surfaces, allowing for improved joint function. The device is contoured to match the natural shape of the humeral head, facilitating a more natural range of motion post-surgery.
Clinical Applications
This device is commonly used in orthopedic surgery, specifically in procedures involving the shoulder joint. It is suitable for patients with osteochondral defects or degenerative joint conditions. The system is typically used in hospital settings or specialized orthopedic centers, and it is particularly beneficial for patients who are not candidates for total shoulder arthroplasty.
Indications for Use
The FDA indications suggest that this device is intended for patients with joint surface damage in the shoulder, such as those with osteochondral defects. It is used to restore joint congruity and function.
Practical Considerations
The device comes in various sizes to accommodate different patient anatomies. It is important to ensure proper sizing and alignment during implantation to achieve optimal outcomes. Compatibility with existing surgical instruments and techniques is generally high, but surgeons should be familiar with the specific implantation procedure.
Related Literature
The linked study investigated the use of a high-density porous polyethylene implant for osteochondral reconstruction in a non-weight-bearing joint model. It demonstrated that the implant could be contoured to fit joint defects and support cellular ingrowth for cartilage resurfacing. While promising, the study was conducted in an avian model, which may limit direct applicability to human clinical scenarios.
Frequently Asked Questions
What is the contoured articular prosthesis cap humeral head resurfacing system used for?
It is used to resurface the humeral head in the shoulder joint, particularly in patients with joint surface damage.
What specialties typically use this device?
Orthopedic surgeons, especially those specializing in shoulder surgeries, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with osteochondral defects or degenerative joint conditions in the shoulder, aiming to restore joint function and congruity.
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.