FDA Clears ZuriMED Rotator Cuff Reinforcer

FDA has cleared a ZuriMED Technologies 510(k) for the FiberLocker System for rotator cuff repair reinforcement. Traditional repair techniques often fail at the suture-tendon interface, which leads to retears that require further surgeries and longer recovery times, according to the company. Its FiberLocker system is designed to reinforce soft tissue repairs at the time of surgery to improve traditional repair techniques, it says.

The device comprises two components — a patch (SpeedPatch PET), which is implanted onto the repaired tendon, and a single-use instrument (FiberLocker Instrument) that is designed to facilitate its fixation. “Made of non-woven polyethylene terephthalate (PET) fibers, the patch acts as medical felt,” the company says. “During surgery, the FiberLocker Instrument employs a reciprocating needle that pushes the fibers into the underlying tendon tissue, creating an interwoven construct that securely integrates the implant to the tendon.”