After years of development, Fusion Orthopedics is pleased to announce the DynaBridge System as the newest addition to their product offering. FDA 510(k) clearance was issued October 15th, 2018. The assigned FDA 510(k) # for DynaBridge is K181815.
The system is indicated for fracture and osteotomy fixation and joint arthrodesis in the hand and foot. The comprehensive offering comprises 15 unique implants in both gamma sterile packaged and steam sterile tray based configurations to address a spectrum of surgical indications.
DynaBridge is a patent-pending comprehensive nitinol shape memory implant system with a design that is engineered to combine high strength with uniform compression. The nitinol material exhibits continuous elastic properties which exert force across a fusion site both before and after resorption or movement. Unlike many other nitinol implants currently being utilized on the market, the implant does not require heating nor freezing.
The system comes in both a simple sterile system and is available in a steam sterilized tray environment alongside our signature FuzeFix screws. The staple provides reproducible and constant bicortical compression with minimal disruption to the osteotomy or fracture site. Fusion has made significant strides developing best in class instrumentation for staple delivery with both a single use and reusable option.
This FDA clearance creates significant opportunity for growth Fusion and represents yet another substantial milestone in the development of its product portfolio.
Contact:
Fusion Orthopedics, LLC.
FDA@FusionOrthopedics.com
Phone: 800-403-6876
