Inovedis earns FDA clearance for rotator cuff implant system


Medical technology start-up Inovedis has received FDA clearance for its Sinefix implant system for rotator cuff repairs. 

The system is a simplified surgical technique for refixation of the rotator cuff tendon to the bone, according to a July 6 news release. 

In the procedure, the base plate is positioned and the fixation points are then driven into the bone. The system can be used with both arthroscopic and open reconstruction techniques. 

The goal of the system is to reduce the amount of time and money spent on rotator cuff repair procedures. 

Sinefix will initially be used at clinical sites in a limited market release, the release said.

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