Holland, Michigan-based Shoulder Innovations, LLC has received FDA clearance for its InSet Plus™augmented glenoids for the InSet™Total Shoulder System.
FDA 510(k) Clearance for Shoulder Innovations’ InSet Plus
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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.”
“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.”
Running told OTW, “InSet’s humeral stem design combined with the unique InSet glenoid implant, allows for a bone-sparing surgery for various humeral or glenoid deformities. We now have long term clinical results verifying its success.”
“Jeff Ondrla and I both had significant design roles with the original design and development of some of the first onlay pegged glenoids introduced to the market many years ago, which are still heavily used today.”
“It is both humbling and exciting to now see the significant improvements of our InSet glenoid design compared to our original designs of the first onlay glenoids. I am quite sure this is why Jeff and I have flat spots on our foreheads now, after hitting them so many times, saying to ourselves, ‘How did we miss something so simple and yet so elegant and creatively different? It’s Brilliant!’
“The InSet also offers streamlined and straightforward instrumentation, with a focus on bone preservation, which also allows the surgeon to reproduce native anatomy. Shoulder Innovations set out to innovate and we have delivered a unique and simple solution that surgeons have wholeheartedly embraced.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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