Solana Surgical Receives FDA Clearance, Launches the FuseFORCE™ SuperElastic Fixation System (press release)
Solana Surgical, LLC (Solana), a growth extremity company, announces the launch of the FuseFORCE™ SuperElastic Fixation System, a new implant system for orthopedic and podiatric surgeons’ use in fusing the small joints in the foot and ankle, and hand and wrist. Commercialization follows a successful FDA 510K clearance in mid-July.
“Hospitals and surgery centers are beginning to request pre-sterilized implants and instruments as a way to reduce their own sterile processing and liability costs. Solana is a leader in the extremity market for this innovation”
The FuseFORCE System consists of a complete, sterile kit containing super-elastic Nitinol (memory metal) staples, and all of the instruments required for implantation. A specially-designed inserter allows the implant to be loaded without handling by the surgeon.
Unlike other Nitinol implants on the market, the FuseFORCE implant requires no heat to activate its compressive properties. “The super-elastic properties of the FuseFORCE Implant allow the implant legs to act as springs, rather than relying on heat for activation....
