Shoulder Innovations Announces FDA 510(k) Clearance For Shoulder Technology
HOLLAND, Mich., Nov. 5, 2018 /PRNewswire/ — Shoulder Innovations announced today that they have received FDA clearance for their InSet Humeral Short Stem System. 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.
Peter Johnston, M.D. of Southern Maryland Orthopaedic and Sports Medicine 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.”
Robert Tashjian, M.D. of the University of Utah added, “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.”
Rob Ball, Executive Chairman of Shoulder Innovations 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.
About Shoulder Innovations:
Shoulder Innovations, LLC is a medical device development company which designs and commercializes innovative products which demonstrate the potential for improved patient care and reduced overall cost to the healthcare system.
Leveraging its breakthrough, patented, inset glenoid design, Shoulder Innovations is commercializing a shoulder replacement implant system focused on improving outcomes related to the greatest cause of shoulder replacement failure: glenoid loosening.
The InSet technology has been shown in testing to significantly reduce glenoid implant micro-motion and simplifies the surgical technique, potentially reducing complications or increase implant longevity.
Shoulder Innovations is based in Holland, Mich.
Learn more about Shoulder Innovations and its Total Shoulder Replacement System at shoulderinnovations.com.