Shoulder Innovations receives FDA clearance for new glenoid technology

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Shoulder Innovations received FDA 510(k) clearance for its InSet Plus augmented glenoids for the InSet Total Shoulder System.

According to a company press release, the InSet Plus glenoids feature an angled articular surface available in both 5° and 10° variants with multiple diameters. The InSet Total Shoulder System is intended for patients with degenerative, rheumatoid and traumatic disease of the glenohumeral joint and avascular necrosis of the humeral head.

“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,” Don Running, vice president of research and development for Shoulder Innovations, said in the release. “In addition, due to the circular nature of the implant design, surgeons are able to dial the augmentation to provide stability in multiple positions.”

According to the release, results from a study published in the Journal of Shoulder and Elbow Surgery showed an improvement in implant stability with the InSet Shoulder System, with an 87% reduction in implant micro-motion compared with conventional glenoid design.

“We are excited to see the InSet glenoid product line expanded to include our InSet Plus glenoid,” David Blue, chief commercialization officer for Shoulder Innovations, said in the release. “This innovation shares the same simplicity of our primary InSet glenoid, while offering surgeons the opportunity to simply ‘dial-in’ the desired correction. The long-term vision of Shoulder Innovations is to offer a complete leading technology shoulder arthroplasty product line and the addition of the InSet Plus is another step in that direction.”


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