Shoulder Innovations today announced that it received FDA 510(k) clearance for its InSet stemless humeral system.
Grand Rapids, Michigan–based Shoulder Innovations designed the stemless humeral system as the latest component of the InSet total shoulder system. It combines stemless and stemmed in both anatomic and reverse configurations in the same platform.
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Shoulder Innovations this week announced that it has received FDA 510(k) clearance for its InSet Reverse shoulder arthroplasty system.
Holland, Mich.-based Shoulder Innovations designed the InSet system with AI-enabled 3D PreView software planning for precise implant selection and placement. It has been shown in testing to significantly reduce glenoid implant micro-motion and simplifies surgical techniques to increase implant longevity, according to the company.
“Shoulder Innovations has been preparing for this product release for many months. The FDA clearance and upcoming launch of the InSet Reverse shoulder represent a significant inflection point for all aspects of the Shoulder Innovations business. Early indications of customer demand for this technology have been very high, and we’re ready to deliver this unique product to our clinical partners to enable excellent patient care,” chief operating officer Matt Ahearn said in a news release.…