Startup surgical device developer First Ray said today it won FDA 510(k) clearance for its SpeedButton system designed to attach soft tissue to bone.
The SpeedButton device attaches soft tissue to bone through a transosseous fixation technique to attach to the cortical bone opposite the soft tissue reattachment site, the Logan, Utah-based company 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. 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,” Dr. Charles Saltzman of the University of Utah said in a press release.
First Ray said its SpeedButton system will be offered in a sterile procedure pack containing everything necessary for soft tissue reattachment procedures.
The post First Ray wins FDA nod for SpeedButton soft-tissue-to-bone attachment device appeared first on MassDevice.