FDA Grants 510(k) Clearance to Shoulder Innovations’ InSet Humeral Implant

Shoulder Innovations has received the FDA’s 510(k) clearance for a new component of its InSet total shoulder system, a stemless humeral implant.

The shoulder system includes both stemless and stemmed components in various configurations. The new InSet Stemless humeral system makes use of the same instruments and surgical techniques, but allows for more flexibility during procedures.

“Previously, surgeons had to choose—stem or stemless—for each surgical case without the option to easily change from one to the other,” the Grand Rapids, Mich.-based company said.