Small Bone Innovations (SBi), an orthopedics company, has received 510(k) pre-market clearance notifications from the FDA for mini-rail fixation System (Mini-Rail System) and large cannulated screw system for use in lower limb reconstruction and repair procedures.
The mini-rail and cannulated screw systems further expand SBi’s lower limb continuum of care product line. SBi expects its mini-rail system to be used in common procedures such as MTP (metatarsophalangeal) joint arthrodesis and distraction, subtalar fusion and Jones fracture management. There are approximately 65,000 of these procedures performed annually in the US.
The mini-rail system is an adjustable fixation system that let surgeons quickly achieve optimal placement in the bones of fixation ‘half’ pins. The system’s ease of use can decrease OR time. It was launched following a series of extensive evaluations by US foot and ankle surgeons.
SBi expects the large cannulated screw system, made out of stainless steel, to be used for a variety of foot and ankle procedures including triple arthrodesis, subtalar and ankle fusions. There are approximately 50,000 of these procedures performed annually in the US.
Guido LaPorta, chief of foot and ankle surgery at community medical center, Scranton PA, said: “The SBi mini-rail system offers a versatile solution for small bone reconstruction and trauma. The system’s design allows it to be used as primary or complementary fixation in arthrodesis, osteotomy, bone lengthening and fracture repair. The system’s unique instrumentation allows us to employ the mini-rail system as an anatomically accurate and rigid construct.”
Anthony Viscogliosi, chairman and CEO of SBi, said: “Both the systems have been designed specifically for use in a wide range of lower limb procedures to reinforce and enhance the company’s goal of developing the most attractive, anatomically-focused product portfolio available for use by foot and ankle surgeons.
“These systems reinforce SBi’s commitment to work with key opinion leaders to provide product solutions that serve the full range of clinical needs of surgeons and their patients.”