Holland’s Shoulder Innovations Receives FDA Clearance for Budge-resistant Shoulder Replacement

Holland, Mich.-based Shoulder Innovations, which develops shoulder replacement systems, has received U.S. Food and Drug Administration clearance for its InSet Plus augmented glenoids for the InSet Total Shoulder System. The technology prevents shoulder replacements from moving after surgery.
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Shoulder Innovations InSet Total Shoulder System diagram
Shoulder Innovations’ InSet Total Shoulder System improves shoulder replacement technology by preventing the replacements from moving. // Image courtesy of Shoulder Innovations

Holland, Mich.-based Shoulder Innovations, which develops shoulder replacement systems, has received U.S. Food and Drug Administration clearance for its InSet Plus augmented glenoids for the InSet Total Shoulder System. The technology prevents shoulder replacements from moving after surgery.

The system is used to treat significant disability in degenerative, rheumatoid and traumatic diseases of the glenohumeral joint and avascular necrosis of the humeral head. It includes inset glenoid technology invented by Dr. Stephen Gunther and features an angled articular surface. It is available in 5-degree and 10-degree variants with multiple diameters.

“In the United States, there are more than 100,000 total shoulder patients operated on annually, with demand for the procedure growing at approximately 10 percent per year,” says David Blue, chief commercialization officer. “Surgeons are seeking implant systems that can help to reduce implant loosening and revision rates, therefore increasing patient satisfaction and reducing overall health care costs.”

Results published in the Journal of Shoulder and Elbow Surgery show improved implant stability with the system, demonstrating an 87 percent reduction in implant micro-motion as compared to conventional glenoid design. Additional results published in the journal show there were no complications, cases of glenoid implant loosening, or revision surgeries performed in the series at a mean 8.7 year follow up.

“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,” says Don Running, vice president of research and development. “With the new InSet Plus design, surgeons have the ability to create optimal pocket depths on more eroded glenoid faces while still providing significant version correction. In addition, due to the circular nature of the implant design, surgeons are able to dial the augmentation to provide stability in multiple positions.”

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