FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit

The FiberLocker System is a surgical device consisting of a polyester felt implant and a micro-stapling instrument used to reinforce the rotator cuff following or during repair by suture or suture anchors. It is not intended to replace normal body structures or provide full mechanical strength, as sutures and bone anchors provide the primary structural support.

The FiberLocker Implant and Instrument are unchanged from the predicate device. The key difference is the addition of the FiberLocker PowerUnit as an alternative power source to the previously cleared DYONICS shaver system. The PowerUnit operates at a fixed speed of 2500 rpm (versus the shaver's variable 500–5000 rpm range) and is battery-powered rather than mains-powered, with identical functional interface and actuation mechanisms.

Software documentation and validation, electrical safety and EMC testing per IEC 6060, cleaning validation, and steam sterilization validation.

The subject device is substantially equivalent because it has identical indications for use as the predicate FiberLocker System (K241219), with no changes to the implant or instrument themselves. The PowerUnit's fixed-speed design and battery power are minor design differences that do not raise new safety or effectiveness questions, as the basic mechanism of electrical power remains unchanged and is supported by software validation and electrical safety testing.