Shoulder Innovations today announced that it received FDA 510(k) clearance for its InSet stemless humeral system.
Grand Rapids, Michigan–based Shoulder Innovations designed the stemless humeral system as the latest component of the InSet total shoulder system. It combines stemless and stemmed in both anatomic and reverse configurations in the same platform.
“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,” CEO Rob Ball said in a news release. “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.”
The company’s InSet technology uses instruments and surgical techniques as the existing InSet Humeral Short stem to allow for flexibility for intraoperative decision-making.
“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,” chief operations officer Matt Ahearn said.