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KATOR Receives FDA 510(k) Clearance for Suture Anchor System


KATOR received FDA 510(k) clearance (K152236) to market the KATOR Suture Anchor System.

In arthroscopic rotator cuff repair, the KATOR system provides knotless fixation with suture anchors that are loaded with four high-strength sutures, with the ability to tension each suture independently.

According to company-reported data, repairs using one KATOR suture anchor have been shown to yield double the fixation strength of repair constructs using other market-leading suture anchors, which may enable the use of fewer suture anchors per procedure.

KATOR is a medical device company incubated and operated by Surgical Frontiers. Yesterday, KATOR announced receipt of a U.S. Patent for the technology that supports this suture anchor system.

Source: KATOR, LLC