FDA clears augmented glenoids for Shoulder Innovations system
Shoulder Innovations announced today that it won FDA clearance for its InSet Plus augmented glenoids for the InSet total shoulder system.
The Holland, Mich.-based company’s InSet system is designed to treat significant disability in degenerative, rheumatoid and traumatic disease of the glenohumeral joint and avascular necrosis of the humeral head. Shoulder Innovations said its product is supposed to simplify shoulder replacement technology.
With the new InSet Plus augmented glenoids, the system includes an angled articular surface. The glenoids are available in both 5° and 10° variants with multiple diameters, according to a news release.
The InSet Shoulder System demonstrated improved stability with an 87% reduction in implant micro-motion when compared to standard glenoid design, according to data published in the Journal of Shoulder and Elbow Surgery (JSES). The results also found no complications, no cases of glenoid implant loosening and no revision surgeries at the mean 8.7-year follow-up.
“We are excited to see the InSet glenoid product line expanded to include our InSet Plus glenoid,” Shoulder Innovations chief commercialization officer David Blue 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. Surgeons appreciate the fact that they don’t have to commit to a specific configuration until they are at the trial stage and no new instrumentation is required for this benefit. 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.”
“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,” added Shoulder Innovations VP of R&D Don Running. “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.”