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Shoulder Innovations Inc., received FDA 510(k) clearance for their InSet Reverse Shoulder Arthroplasty System. The company expected to begin surgical cases within days of the announcement.
The latest clearance rounds out the company’s product line for shoulder replacement including:
- AI-enabled 3D PreView Software Planning solution to help ensure a more precise implant selection and placement
- Broad range of implant types representing 6 different products, seamlessly integrated into one instrument tray and optimized for procedure efficiency and ASC environments
- Convertible humeral platform
- Innovative instrumentation for the simplest possible surgery
- Published long-term clinical data proving the effectiveness of the InSet system
“We’ve been able to package not 2, but 6 products in one instrument tray, an unmatched efficiency in the marketplace,” said Rob Ball, CEO of Shoulder Innovations. “This includes all options necessary to treat glenoid deformity from simple to complex. 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.”
