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.
“Our team is very excited to bring the Reverse system to market. While it indeed provides for game-changing simplicity, it simultaneously resolves many significant technical and clinical challenges faced by orthopedic specialists seeking to offer optimal outcomes to their patients. We’ve been able to package not 2, but 6 products in one instrument tray, an unmatched efficiency in the marketplace. This includes all options necessary to treat glenoid deformity from simple to complex,” CEO Rob Ball said. “This comes with published long-term proof of excellent outcomes for our InSet technology. Our humeral fixation is unmatched and offers the simplest technique on the market. Our technical team working with our clinical team has assembled a truly special solution, and together with our recent equity financing, Shoulder Innovations is very well positioned to bring value for all stakeholders in the care event.”