First Ray Receives FDA 510(k) Clearance for SpeedButton Soft Tissue Attachment System

By Julie A. Vetalice

First Ray received FDA 510(k) clearance to market the SpeedButton™ system for attachment of soft tissue to bone. SpeedButton will be offered in a sterile procedure pack comprising all items needed for the soft tissue reattachment procedure.

As compared to suture anchors, SpeedButton addresses issues of fixation quality through a transosseous fixation technique to support strong, reliable fixation in the cortical bone opposite the soft tissue reattachment site.

Extremity procedures that commonly require decortication at the soft tissue attachment site include bunion and bunionette procedures.

This marks the third 510(k) clearance for First Ray, all occurring within 2016.

First Ray is a development stage medical device company incubated and operated by Surgical Frontiers. The company is accepting inquiries regarding distribution and commercialization partnerships.

Sources: First Ray, ORTHOWORLD Inc.

Tags: 510(k) Clearance, Regulatory