Shoulder Innovations Gains FDA Clearance For InSet Reverse Shoulder

By Julie A. Vetalice

Shoulder Innovations Gains FDA Clearance For InSet Reverse Shoulder

Shoulder Innovations received FDA clearance to market their InSet™ Reverse Shoulder Arthroplasty System. First surgical cases will commence shortly.

The InSet Reverse Shoulder system seamlessly integrates and rounds out a best in class product line for shoulder arthroplasty 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 allowing efficient treatment of patients with the simplest to the most complex pathologies, optimized for ASC environments,
  • Convertible humeral platform demonstrating best in class fixation, the only true fully convertible humeral inlay system, and surprising minimally invasive bone preservation.
  • Highly innovative instrumentation providing the simplest possible surgery.
  • Published long term clinical data proving the effectiveness of the InSet system.

David Blue, Chief Commercialization Officer for Shoulder Innovations, said, "Our surgeon customers value having all possible shoulder surgery implants and instruments available in one tray. Not only does our system provide a reduced implant and instrument footprint, but more importantly, the surgeon has access to our primary total shoulder and reverse shoulder including our innovative primary InSet™ and InSet™ Plus glenoid technology all in one place. This convertible system is game-changing and efficient. The InSet™ Platform simplifies shoulder replacement technology in order to improve outcomes."

Matt Ahearn, Chief Operating Officer for Shoulder Innovations, said, "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."

Source: Shoulder Innovations

Product Labels: Shoulder Replacement

Tags: 510(k) Clearance, Regulatory