Incubated device company Kator has gained FDA 510(k) clearance for its suture anchor system that claims to outperform some of the market leaders.
Background
Now that suture anchors for use in shoulder stabilisation are getting on for thirty years old, it’s a bold move to claim significant advances, paradigm shifts or game-changing advances. However, that’s exactly what device company Kator is saying about its KATOR Suture Anchor System, claiming that it represents a “new paradigm in tissue-to-bone reattachment.”
The device, as applied to arthroscopic rotator cuff repair surgery, provides knotless fixation with suture anchors that are loaded with four high-strength sutures, with the ability to independently tension each suture.
The claim is that repair constructs using a single KATOR suture anchor have been shown to have double the fixation strength when compared to repair constructs using certain market leading suture anchors (referring to data on file). The implication is that surgeons can repair torn rotator cuffs using fewer suture anchors, preserving more bone and increasing the “footprint” area available for tendon healing.
KATOR is a medical device company incubated and currently operated by Surgical Frontiers, a company that funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use. Focused primarily on musculoskeletal injuries and pathologies, Surgical Frontiers says it collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.
Source: PR Newswire
published: November 10, 2015 in: Approval/Clearance, News, Shoulder