Shoulder Innovations Announces FDA 510(K) Clearance for InSet™ Reverse Shoulder Platform Technology

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HOLLAND, Mich., August 23, 2021 — Shoulder Innovations Inc, a leading innovator in the development of shoulder replacement systems, announced today that they have received FDA clearance for their InSet™ Reverse Shoulder Arthroplasty System.

The InSet™ Reverse Shoulder system seamlessly integrates and rounds out a best in class product line for shoulder arthroplasty including:

  • Class leading 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.

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