Solana Surgical Launches Extremities Joint Fusion System

Solana Surgical LLC has unveiled a new implant system that fuses small joints in the foot/ankle and hand/wrist.

The company’s FuseFORCESuperElastic Fixation System consists of a sterile kit containing super-elastic Nitinol (memory metal) staples, and the necessary instruments for implantation. A specially-designed inserter allows the implant to be loaded without it first being handled by the surgeon.

Unlike other Nitinol implants on the market, the FuseFORCE implant requires no heat to activate its compressive properties, company executives claim.

“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,” explained Rebecca Wahl, Solana’s vice president of research and development.

The compression-ready FuseFORCE system has a stepped tooth design to resist pull from the bones being stabilized. The device provides a constant compression force due to a “compression on release” design that does not require heat activation like some other nitinol-based devices.

The shape memory device is delivered sterile along with a disposable implant kit in a package that includes the implant, inserter, reamer, reamer guide and locator pin. In a typical fixation procedure using the FuseFORCE system, holes are drilled in the bones being fused using the reamer guide and laser marked reamer. Tips of the nitinol implant are then aligned to the holes and inserted flush to the bone. The plastic inserter is twisted counter-clockwise to release the implant, The twist-release-compress mechanism of the inserter and implant combination results in an effortless “no-touch” deployment and implant positioning can be evaluated radiographically after implantation. The system is available in sizes ranging from 8×8 mm to 25×22 mm with corresponding leg diameters matched to overall size.

A sterile, single use system, the FuseFORCE kit does 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 President/CEO Alan Taylor noted.

The FuseFORCEsystem received U.S. Food and Drug Administration 510(k) clearance in mid-July.