Shoulder Innovations has secured 510(k) Clearance from the US Food and Drug Administration (FDA) for its InSet Humeral Short Stem System.
Image: Shoulder Innovations gets FDA 510(k) clearance for InSet Humeral Short Stem system. Photo: Courtesy of yodiyim/FreeDigitalPhotos.net.
This is a key addition to their expanding shoulder portfolio and another milestone for their vision to offer a complete leading technology shoulder arthroplasty product line.
The clearance covers products used for partial or total shoulder arthroplasty used in the treatment of degenerative, rheumatoid or traumatic arthritis in the shoulder.
The new InSet Shoulder system provides innovative features and solutions to address potential problems encountered with current total shoulder replacement systems.
Southern Maryland Orthopaedic and Sports Medicine Peter Johnston said: “The strengths of the InSet Shoulder System are its streamlined instrumentation, proprietary coating technology for implant fixation with bone preservation and ability to reproduce native humeral anatomy. The system is game-changing.”
University of Utah Robert Tashjian said: “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.”
Shoulder Innovations executive chairman Rob Ball said: “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 has also recently announced new investments that will be used to fuel new product development, and to acquire inventory and assets to accelerate growth of its current InSet platform technology. This technology serves as a foundational platform on which many future products and systems are in development.
The long-term vision of Shoulder Innovations is to offer a complete leading technology shoulder arthroplasty product line.
Source: Company Press Release