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buechel-pappas humeral head resurfacing component
Endotec
Summary: The Buechel-Pappas Humeral Head Resurfacing Component is a medical device used in orthopedic surgery to resurface the humeral head, typically in patients with shoulder joint issues. It is primarily used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K992394 ↗
Decision Date
October 15, 1999
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The Buechel-Pappas Humeral Head Resurfacing Component was cleared by the FDA via the 510k pathway on October 15, 1999. It is manufactured by Endotec and is classified as a Class 2 device.
What It Is
The Buechel-Pappas Humeral Head Resurfacing Component is an orthopedic implant designed to resurface the humeral head, which is the upper part of the arm bone that fits into the shoulder socket. This device is used in shoulder arthroplasty procedures to restore joint function and alleviate pain in patients with degenerative joint diseases or trauma. It is made from biocompatible materials to ensure durability and compatibility with the human body.
Clinical Applications
This device is commonly used in orthopedic surgical settings, particularly in procedures involving shoulder joint reconstruction or replacement. It is suitable for patients suffering from conditions such as osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the shoulder. Orthopedic surgeons use this device to improve joint mobility and reduce pain in patients who have not responded to conservative treatments.
Indications for Use
The FDA-cleared indications for this device include its use in patients who require shoulder joint resurfacing due to degenerative conditions or trauma. It is intended for individuals who experience significant pain and reduced mobility in the shoulder joint.
Practical Considerations
The Buechel-Pappas Humeral Head Resurfacing Component 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 maximize the device's effectiveness and longevity. Compatibility with other shoulder prosthetic components should be verified prior to surgery.
Frequently Asked Questions
What is the Buechel-Pappas Humeral Head Resurfacing Component used for?
It is used to resurface the humeral head in shoulder arthroplasty procedures, primarily to treat degenerative joint diseases or trauma.
What specialties typically use this device?
Orthopedic surgeons typically use this device in shoulder reconstruction or replacement surgeries.
What are the FDA-cleared indications?
The device is indicated for patients requiring shoulder joint resurfacing due to degenerative conditions or trauma, aiming to alleviate pain and improve mobility.
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.