FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)

The FiberLocker System is a surgical mesh device consisting of a polyester felt implant and a micro-stapling instrument designed to reinforce the rotator cuff following or during surgical repair. It augments weakened soft tissue but does not replace normal structures or provide full mechanical strength; sutures and bone anchors provide the primary support.

The FiberLocker System is a synthetic non-woven polyester patch that integrates with soft tissue, compared to the predicate Pitch-Patch which is a knitted mesh with fibers. Although physical properties differ (e.g., porosity), both devices are non-resorbable, provide adequate mechanical strength, elicit acceptable biological response, and are sterilized by irradiation.

Not stated in this summary. The document references compliance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh but does not cite specific ISO, IEC, or ASTM standards.

The FiberLocker System shares the same intended use, indications, and principles of operation as the predicate Pitch-Patch. Bench testing demonstrates appropriate mechanical properties (density, porosity, tensile strength, tear resistance, suture pull-out). Animal studies in an ovine infraspinatus tendon model showed equivalent biomechanical performance, functional outcomes, and biological response at 6 and 12 weeks between the FiberLocker implant and predicate at both systemic and local tissue levels. Minor technological differences (non-woven vs. knitted construction) raise no new safety or effectiveness concerns.