Tornier issued FDA clearance for shoulder arthroplasty offering

Tornier recently announced they have received FDA clearance to market the Simpliciti Shoulder System.

Indicated for use in total shoulder arthroplasty, the Simpliciti Shoulder System was designed in conjunction with shoulder surgeons to treat patients exhibiting severe shoulder pain as well as lessened range of motion, strength, and functionality as a result of osteoarthritis (OA) or traumatic arthritis. The goals of the system are to alleviate these symptoms, minimize surrounding soft tissue damage, and preserve the native bone in the area.

The Simpliciti Shoulder System boasts a humeral component to aid in anatomic placement without the constraints of normal stemmed systems. Tornier believes the advantages of the system can allow for earlier intervention in younger patients with shoulder OA.

"We are very pleased with…the FDA's swift clearance of this innovative product,” Dave Mowry, president and chief executive officer of Tornier, stated in a company release. "We plan to introduce the Simpliciti product through a measured process to ensure education and training paces our product deployment. We believe building long-term success in this new category will take an investment in training and education while allowing the market time to develop."

Reference: http://www.tornier.com/