Medical device firm First Ray has secured 510(k) clearance from the US Food and Drug Adminsitration (FDA) for its SpeedButton system to attach soft tissue to bone.
Conventional suture anchors usage in the reattachment of ligaments and capsular tissue is tough in the presence of decortication at the attachment site.
Quality of the fixation is expected to be compromised, as well as suture anchor occupy and occlude a portion of the soft tissue footprint available for healing.
SpeedButton system uses transosseous fixation technique to solve these issues, which provides dependable fixation in the cortical bone opposite the soft tissue reattachment site.
According to the company, the 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.
The company is providing the SpeedButton system in a sterile procedure pack, which includes all materials required for the soft tissue reattachment procedure.
University of Utah orthopaedics department chairman Dr Charles Saltzman said: "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."