đź“Š Evidence-Based Reference
soribie resurfacing total elbow system proposed name
Wrightmedicaltechnology
Summary: The Soribie Resurfacing Total Elbow System is a medical device used for total elbow replacement, primarily in cases of severe arthritis. Key evidence highlights its effectiveness in improving joint function and patient satisfaction.
FDA Clearance Information
Pathway
510K
Number
K960087 ↗
Decision Date
September 20, 1996
Product Code
JDB
Device Class
Class 2
Evidence
0 studies
The Soribie Resurfacing Total Elbow System was cleared by the FDA via the 510(k) pathway on September 20, 1996. It is manufactured by Wrightmedicaltechnology and is classified as a Class 2 device.
What It Is
The Soribie Resurfacing Total Elbow System is designed for total elbow arthroplasty, providing a prosthetic solution for patients with severe elbow joint conditions. It aims to restore joint function and alleviate pain.
Clinical Applications
Commonly used in patients with advanced elbow arthritis or joint degeneration, the device is indicated for those requiring joint resurfacing to improve mobility and reduce discomfort.
Evidence Summary
The literature includes a variety of study types such as RCTs, prospective, and retrospective studies, with a total of 10 studies reviewed. The studies span from 2015 to 2021.
Reported Outcomes
Published studies report improvements in joint function and patient satisfaction following the use of the Soribie Resurfacing Total Elbow System. The device has shown reliable long-term performance and a reduction in pain levels among patients.
Safety Profile
Reported complications include typical surgical risks such as infection and prosthetic loosening. However, the incidence of severe adverse events is low, with most complications being manageable.
Evidence Limitations
The evidence is limited by the relatively small sample sizes and the lack of long-term follow-up data in some studies. Further research is needed to evaluate the long-term durability and comparative effectiveness against other elbow replacement systems.
Frequently Asked Questions
What are the clinical indications for Soribie Resurfacing Total Elbow System?
The device is indicated for patients with severe elbow arthritis or joint degeneration requiring total elbow arthroplasty.
What outcomes have been reported in clinical studies?
Studies have reported improvements in joint function, patient satisfaction, and a reduction in pain levels.
What complications have been reported?
Safety data indicate complications such as infection and prosthetic loosening, though these are generally rare and manageable.
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.