Shoulder Innovations Receives FDA Clearance for InSet Stemless Humeral Implant

By Julie A. Vetalice

Shoulder Innovations Receives FDA Clearance for InSet Stemless Humeral Implant

Shoulder Innovations announced FDA 510(k) clearance of their latest component of the InSet™ Total Shoulder System, the InSet™ Stemless Humeral System. The InSet Stemless implant is the latest addition to the integrated InSet shoulder replacement system, which already includes the InSet Glenoid, Humeral Short Stem and Reverse components.

The InSet Stemless device will be available at select U.S. sites in the coming weeks.

The new Stemless device is a component of what the company calls the first truly integrated shoulder system in the world, combining stemless and stemmed, in both anatomic and reverse configurations in the same platform.

This platform makes use of the same instruments and surgical techniques as the existing InSet Humeral Short stem, allowing flexibility for intraoperative decision-making. The design for the humeral preparation allows for the least amount of bone removal, while the implant's curved fin design is intended to maximize axial and rotational fixation surface area.

Source: Shoulder Innovations

Product Labels: Shoulder Replacement

Tags: 510(k) Clearance, Regulatory