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seviin surface replacement shoulder
Ingen Orthopedics
Summary: The Seviin Surface Replacement Shoulder by Ingen Orthopedics is a device used in shoulder arthroplasty. It is primarily indicated for patients with glenohumeral arthritis. Key evidence highlights its role in improving joint function and reducing pain.
FDA Clearance Information
Pathway
510K
Number
K130635 ↗
Decision Date
August 26, 2013
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The Seviin Surface Replacement Shoulder was cleared by the FDA through the 510(k) pathway on August 26, 2013. Manufactured by Ingen Orthopedics, it is classified as a Class 2 device under product code HSD.
What It Is
The Seviin Surface Replacement Shoulder is a prosthetic device designed for shoulder arthroplasty. It replaces the articular surface of the shoulder joint, aiming to restore joint function and alleviate pain in patients with degenerative joint conditions.
Clinical Applications
This device is commonly used in patients with glenohumeral arthritis, particularly when conservative treatments have failed. It is also considered in cases of cuff tear arthropathy where traditional shoulder replacements may not be suitable.
Evidence Summary
The literature includes 10 studies, comprising systematic reviews and clinical trials, published between 2014 and 2021. These studies explore various aspects of shoulder arthroplasty, including rehabilitation guidelines and revision outcomes.
Reported Outcomes
Published studies report that the Seviin Surface Replacement Shoulder can effectively improve joint function and reduce pain in patients with shoulder arthritis. Outcomes from revision surgeries indicate a satisfactory restoration of shoulder mechanics.
Safety Profile
Reported complications include periprosthetic joint infections, with Propionibacterium acnes being a common pathogen. The studies highlight the need for effective antimicrobial prophylaxis to mitigate infection risks.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of long-term follow-up data. Further research is needed to establish standardized rehabilitation protocols and to evaluate long-term device performance.
Frequently Asked Questions
What are the clinical indications for Seviin Surface Replacement Shoulder?
The device is indicated for patients with glenohumeral arthritis and cuff tear arthropathy, particularly when conservative treatments have failed.
What outcomes have been reported in clinical studies?
Studies report improvements in joint function and pain reduction, with satisfactory outcomes in revision surgeries.
What complications have been reported?
Safety data indicate risks of periprosthetic joint infections, emphasizing the need for effective antimicrobial prophylaxis.
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.