FDA clears Shoulder Innovations InSet short stem shoulder repair system
Emerging medtech developer Shoulder Innovations said today it won FDA 510(k) clearance for its InSet Humeral Short Stem System intended for partial or total shoulder arthroplasty procedures.
The newly cleared system is intended for use in treating degenerative, rheumatoid or traumatic arthritis in the shoulder and includes new features the Holland, Mich.-based company said address potential problems that exist with current total shoulder replacement systems.
“The combination of the InSet Humeral Stem and Shoulder Innovation’s unique InSet glenoid implant affords a surgically simple, bone sparing option for many types of humeral or glenoid deformities associated with arthritis,” Dr. Robert Tashjian of the University of Utah said in a prepared statement.
“We are excited to see the fast-paced progress and results made by the team. Genesis Innovation Group has moved rapidly in developing this highly innovative new product line. It plays a pivotal role in the Shoulder Innovations strategy, and Genesis has proven to be an excellent partner in helping our company move forward,” Shoulder Innovations exec chair Rob Ball said in a press release.
Last month, Shoulder Innovations said that it closed a $2.5 million Series A equity financing round to help support continued product development and growth of its existing Inset technology.