đź“Š Evidence-Based Reference
aequalis resurfacing head
Tornier
Summary: The Aequalis Resurfacing Head by Tornier is a device used primarily for humeral head resurfacing in patients with glenohumeral arthritis. Key evidence highlights its clinical outcomes and safety profile over a follow-up period of up to 5 years.
FDA Clearance Information
Pathway
510K
Number
K062661 ↗
Decision Date
December 22, 2006
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The Aequalis Resurfacing Head was cleared by the FDA via the 510(k) pathway on December 22, 2006. It is manufactured by Tornier and classified as a Class 2 device under product code HSD.
What It Is
The Aequalis Resurfacing Head is a medical device designed for the resurfacing of the humeral head. It is intended for use in patients with degenerative joint disease, specifically glenohumeral arthritis, to restore joint function and alleviate pain.
Clinical Applications
Common clinical scenarios for the Aequalis Resurfacing Head include patients with end-stage glenohumeral arthritis who require joint resurfacing to improve mobility and reduce pain. It is often used in cases where traditional arthroplasty may not be suitable.
Evidence Summary
The available literature includes five studies, comprising clinical trials and observational studies, with a focus on outcomes and safety. The studies span from 2013 to 2017, providing insights into the device's performance over time.
Reported Outcomes
Published studies report that the Aequalis Resurfacing Head demonstrates favorable clinical outcomes, including improved joint function and pain relief, with a mean follow-up of 5 years. CT outcomes also indicate satisfactory joint resurfacing results at least 2 years post-operation.
Safety Profile
Reported complications include typical surgical risks associated with joint resurfacing, though specific adverse events were not detailed in the provided evidence. Overall, the device is considered safe within the studied parameters.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of randomized controlled trials. Further research is needed to establish long-term outcomes and to compare the device's efficacy with alternative treatments.
Frequently Asked Questions
What are the clinical indications for Aequalis Resurfacing Head?
The device is indicated for patients with degenerative joint disease, particularly glenohumeral arthritis, requiring humeral head resurfacing.
What outcomes have been reported in clinical studies?
Studies report improved joint function and pain relief, with positive CT outcomes observed at least 2 years post-operation.
What complications have been reported?
Safety data from evidence indicate typical surgical risks, but specific complications were not detailed in the studies provided.
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.