đź“‹ FDA Reference
neer-iii solid keel glenoid resurfacing prosthesis
Kirschner Medical
Summary: The Neer-III Solid Keel Glenoid Resurfacing Prosthesis is a medical device used in shoulder arthroplasty to replace the glenoid component of the shoulder joint. It is primarily used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K873621 ↗
Decision Date
October 15, 1987
Product Code
KWT
Device Class
Class 2
Evidence
0 studies
The Neer-III Solid Keel Glenoid Resurfacing Prosthesis was cleared through the FDA 510(k) pathway on October 15, 1987, by Kirschner Medical. It is classified as a Class 2 device.
What It Is
The Neer-III Solid Keel Glenoid Resurfacing Prosthesis is an implant used in shoulder arthroplasty to replace the glenoid component of the shoulder joint. It is designed to provide a stable and durable surface for the humeral head to articulate against, thereby improving joint function and reducing pain. The solid keel design helps in anchoring the prosthesis securely to the bone.
Clinical Applications
This prosthesis is commonly used in total shoulder arthroplasty procedures, particularly in patients with degenerative joint diseases such as osteoarthritis or rheumatoid arthritis. It is typically utilized in orthopedic settings, including hospitals and specialized surgical centers. The device is suitable for adult patients who require joint resurfacing due to significant cartilage loss.
Indications for Use
The device is indicated for patients who need glenoid resurfacing as part of a shoulder joint replacement, often due to conditions like osteoarthritis or rheumatoid arthritis that have led to significant cartilage degradation.
Practical Considerations
The Neer-III prosthesis comes in various sizes to accommodate different patient anatomies. It is important for surgeons to select the appropriate size and ensure proper alignment during implantation to optimize outcomes. Compatibility with other shoulder prosthetic components should be verified prior to surgery.
Frequently Asked Questions
What is the Neer-III Solid Keel Glenoid Resurfacing Prosthesis used for?
It is used for glenoid resurfacing in shoulder arthroplasty, primarily to treat conditions like osteoarthritis and rheumatoid arthritis.
What specialties typically use this device?
Orthopedic surgeons specializing in shoulder and joint replacement procedures typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring glenoid resurfacing as part of shoulder joint replacement due to degenerative joint diseases.
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.