Medical device firm Kator has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new knotless suture anchor system.
Earlier, the Kator suture anchor system was approved for use with #2 high strength suture.
The new FDA approval allows to expand the system for use with 2mm wide high strength suture tape.
Produced by using PEEK material, the single Kator suture anchor has received FDA approval for use with up to 4 strands of #2 suture or up to 2 strands of 2mm wide suture tape.
The Kator syste, which is a new paradigm in tissue-to-bone reattachment, aggregates a transosseous technique with knotless suture anchor fixation to offer repair constructs with better strength.
By using less suture anchors, Surgeons can repair torn rotator cuffs or reattach Achilles tendons. It helps to preserve more bone, increase footprint area and enhance blood flow available for tendon healing.
Operated by Surgical Frontiers, Kator is engaged in the development of advanced surgical technologies focusing primarily on musculoskeletal injuries and pathologies.
The company collaborates with surgeons, industry, universities, and investors to bring novel products to the market.
Surgical Frontiers is involved in funding, launching and operating start-up companies to develop advanced surgical technologies that are ready for clinical use.