KATOR Receives FDA Clearance for Knotless Suture Anchor System
LOGAN, Utah, November 8, 2016 – KATOR, a start-up medical device company focused on advanced tissue-to-bone reattachment systems, announces that it has received its second FDA 510(k) clearance for its innovative KATOR Suture Anchor System.
The KATOR Suture Anchor System was previously cleared by the FDA for use with #2 high strength suture. This new FDA clearance now expands the system for use with 2mm wide high strength suture tape. Made from PEEK material, a single KATOR Suture Anchor is now FDA cleared for use with up to 4 strands of #2 suture or up to 2 strands of 2mm wide suture tape.
The KATOR Suture Anchor System represents a new paradigm in tissue-to-bone reattachment. The system combines a transosseous technique with knotless suture anchor fixation to provide repair constructs with superior strength compared to currently marketed suture anchors (data on file).Because of this superior strength, surgeons can repair torn rotator cuffs or reattach Achilles tendons using fewer suture anchors, preserving more bone, increasing the “footprint” area and increasing the blood flow available for tendon healing.
KATOR is a medical device company incubated and operated by Surgical Frontiers.
About Surgical Frontiers
Surgical Frontiers 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, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.