FDA 510(K) CLEARANCE FOR SHOULDER INNOVATIONS’ INSET PLUS

Elizabeth Hofheinz, M.P.H., M.Ed.  /  January 7, 2020

This is an article about portfolio company, Shoulder Innovations.

Holland, Michigan-based Shoulder Innovations, LLC has received FDA clearance for its InSet Plus™augmented glenoids for the InSet™Total Shoulder System.

The system, says the company, is “used to treat significant disability in degenerative, rheumatoid and traumatic disease of the glenohumeral joint and avascular necrosis of the humeral head. The InSet™System includes patented inset glenoid technology, originally innovated by Stephen Gunther, M.D. The new InSet Plus™ glenoids feature an angled articular surface and are available in both 5° and 10° variants with multiple diameters.”

Don Running, vice president, Research and Development for Shoulder Innovations explained, “The key to the long-term clinical success of the InSet™glenoid has been both the unique flat back design and novel bone pocket created in the fossa to allow for a secure fixation that is ‘set in’ the subchondral bone.”

View source version on ryortho.com: https://ryortho.com/breaking/fda-510k-clearance-for-shoulder-innovations-inset-plus/