Solana Surgical Receives FDA Clearance

Officials from Solana Surgical LLC announce 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. 

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. This built-in spring effect creates the compression and fixation needed for many procedures in the foot and hand,” explains Rebecca Wahl, Vice President of Research and Development. 

Fusion is often the preferred procedure to relieve pain and correct skeletal alignment issues in patients with arthritis, as well as small joint fractures and bunions. The FuseFORCE System is available in various sizes for specific surgical needs. 

Pre-Sterilization Saves Hospital Costs 
A sterile, single use system, the FuseFORCE kit is one of many existing and future products developed by Solana that do not require hospital sterilization. 

“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,” says Alan Taylor, president and CEO. 

The FuseFORCE System joins a growing family of Solana Surgical products that include the TenFUSE PIP, TenFUSE Nail, SolaFIX Screw System, MDI Metatarsal Decompression Implant, TenSIX Acellular Dermal Tissue, TenSIX Cancellous Sponge, TenSIX Moldable Putty, and the GaitWAY Implant System.

Source: Solana