FDA clears extremity implant from Utah startup
FDA CLEARS NOVEL EXTREMITY IMPLANT FROM UTAH START-UP (Orthopedics This Week)
Logan, Utah-based extremity implant company, First Ray, hit a key milestone when the FDA gave the firm a 510(k) clearance for additional implants for its innovative Stealth Staple System.
First Ray, a start-up medical device company, designs and is bringing to market mini-implants which target the smaller joints in the body. For example, First Ray’s implants are indicated for hindfoot fusions, first tarsometatarsal joint fusions, midfoot fusion, first metatarsophalangeal fusions and carpal fusions.
The company’s mini size implants were designed for carpometacarpal joint fusions, lesser metatarsophalangeal fusions, and fixation of Akin osteotomies.
First Ray’s mini implants are made from titanium alloy and the more standard sizes come in PEEK (Polyetheretherketone).
According to the company’s press release, the Stealth Staple System is “an intraosseous small bone fixation system used to treat arthrodesis, osteotomies and bone fractures.”
First Ray claims that because the system is entirely embedded in the bone and there is “controlled and evenly distributed compression across the opposing bone surfaces”, the risk for complications is greatly reduced.
First Ray is incubated and operated by Surgical Frontiers, LLC, a financial and investment services company that specializes in medical devices.