Shoulder Innovations’ InSet Stemless Humeral Implant Earns FDA Nod

Shoulder replacement firm Shoulder Innovations has earned U.S. Food and Drug Administration (FDA) for its InSet stemless humeral system, the newest component of its InSet total shoulder system.
 
The new stemless humeral component is part of the integrated shoulder system, combining stemless and stemmed as well as anatomic and reverse configurations in one platform. Surgeons are able to easily change from stem to stemless configurations per their procedural needs, helping reduce operating room time and saving cost on cleaning and sterilization.
 
The humeral component’s design allows minimal bone removal and a curved fin maximizes axial and rotational fixation surface area.
 
“This most recent product clearance from the FDA is a key component to our multi product strategy to provide the simplest and most elegant solutions on the market for shoulder surgery,” Shoulder Innovations CEO Rob Ball told the press. “We have packaged the equivalent of six innovative products in this simple instrumentation set.  We refer to this is as The Power of One, and are proud to bring unmatched efficiency to the market.”
 
Matt Ahearn, COO for Shoulder Innovations added, “The addition of the Stemless system expands the clinical options available to our surgeon partners, with the same anatomic surgical technique and no incremental instrumentation. This is extremely exciting for Shoulder Innovations, as we have significant demand from clinicians who want to pair a Stemless implant with our InSet Glenoid technology.”
 
David Blue, chief commercial officer at Shoulder Innovations further added, “The Stemless implant is another transformational addition to the InSet Shoulder System, where we continue to transcend shoulder science.”
 
The InSet stemless device will be released to select U.S. sites in the next few weeks.