510(k) for First Ray

First Ray, a company focused on orthopedic extremity procedures, has received FDA 510(k) clearance for its SpeedButton System for attachment of soft tissue to bone.

As indicated in the June 2, 2016 news release, “Reattachment of ligaments and capsular tissue to bone using conventional suture anchors is problematic in the presence of decortication at the attachment site. Quality of the fixation may be compromised, and the suture anchor can potentially occupy and occlude a portion of the soft tissue footprint available for healing. The SpeedButton System solves these issues by using a transosseous fixation technique that achieves 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, where an exostectomy is used to remove a painful bony prominence. In these procedures, the site of the exostectomy is the anatomic origin of stabilizing ligaments and joint capsular tissue, and is the preferred site for soft tissue reattachment.”

“The SpeedButton System will be my preferred fixation technique for reattaching the medial collateral ligament and the metatarsosesamoid ligament of the first metatarsophalangeal joint in bunion procedures, as it facilitates direct ligament-to-bone repair of these structures, ” states Charles L. Saltzman, M.D., professor and chairman of the Department of Orthopaedics at the University of Utah. “Additionally, I see exciting potential for earlier surgical intervention with a less invasive procedure to treat the first stage of bunion development. Such a procedure may delay or possibly even preclude the further development of bunion and hallux valgus deformities that require a much more invasive, bone realignment requiring lengthy recovery times for patients.”

Wade Fallin, CEO of First Ray, told OTW, “The SpeedButton Soft Tissue Attachment System is the third product platform to receive FDA 510(k) clearance in the last two months. The other two product platforms recently cleared include the Stealth Staple System for arthrodeses, osteotomies and small bone fractures and the CortiClamp System for small bone fixation. Together, this suite of products addresses a majority of the procedures performed by foot and ankle surgeons. We are looking forward to the upcoming clinical use of these innovative products that have the potential to improve patient outcomes.”