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pritchard surface replacement elbow
Depuy
Summary: The Pritchard Surface Replacement Elbow is a medical device used in elbow joint arthroplasty, particularly for patients with conditions like rheumatoid arthritis. It is primarily used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K810847 ↗
Decision Date
May 1, 1981
Product Code
JDB
Device Class
Class 2
Evidence
0 studies
The Pritchard Surface Replacement Elbow was cleared through the FDA 510(k) pathway on May 1, 1981. Manufactured by Depuy, it is a Class 2 device under product code JDB.
What It Is
The Pritchard Surface Replacement Elbow is a type of elbow prosthesis designed to replace the articulating surfaces of the elbow joint. It is typically used in patients with severe joint damage due to conditions like rheumatoid arthritis. This device allows for improved joint function and pain relief by replacing the damaged surfaces with metal and polyethylene components.
Clinical Applications
This device is commonly used in orthopedic surgery, specifically in total elbow arthroplasty procedures. It is indicated for patients with significant joint degeneration, often due to rheumatoid arthritis or trauma. The device is most suitable for patients with intact bone and ligamentous structures, and it is used in surgical settings by orthopedic surgeons.
Indications for Use
The Pritchard Surface Replacement Elbow is indicated for patients with severe elbow joint damage, often due to rheumatoid arthritis. It is suitable for those with intact bone and ligament support, providing an option for joint replacement to improve function and reduce pain.
Practical Considerations
The device requires precise surgical technique to ensure proper alignment and function. It is available in various sizes to accommodate different patient anatomies. Surgeons should consider the patient's bone quality and ligament integrity when selecting this device.
Related Literature
The linked study examined total elbow arthroplasty in patients with rheumatoid arthritis, highlighting improvements in outcomes due to better patient selection and implant design. It found that semiconstrained implants are suitable for severe cases, while non-constrained surface replacements, like the Pritchard device, require intact bone and ligaments. Limitations include the study's focus on a specific patient population and the need for early intervention.
Frequently Asked Questions
What is the Pritchard Surface Replacement Elbow used for?
It is used for elbow joint replacement in patients with severe joint damage, particularly due to rheumatoid arthritis.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and arthroplasty procedures use this device.
What are the FDA-cleared indications?
The device is indicated for elbow joint replacement in patients with severe damage and intact bone and ligament support.
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.