Solana Surgical (Memphis, TN) has announced the launch of the FDA approved, nitinol-based, FuseFORCE fixation system for fractured bones in the foot. The unique 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 8x8mm to 25x22mm with corresponding leg diameters matched to overall size.
Product Page: FuseFORCE…
Press Release: Solana Surgical Receives FDA Clearance, Launches the FuseFORCE™ SuperElastic Fixation System…