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Orthopedics company gets FDA 510(k) clearance for lower limb reconstruction systems
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Small Bone Innovations, Inc. announced that it had received 510(k) pre-market clearance notifications from the FDA for its mini-rail fixation and large cannulated screw systems which are designed for use in lower limb reconstructions and repairs.
The mini-rail system is an adjustable fixation device that allows surgeons to achieve placement of “half” pins in the bones during fixation, which could potentially reduce operating times, according to a company press release. Small Bone Innovations, Inc. (SBi), expects the system to be used in procedures such as first metatarsophalangeal joint arthrodesis and distraction, subtalar fusion and Jones-fracture management.
The stainless steel cannulated screw system is planned for use in a variety of foot and ankle procedures, including triple arthrodesis, subtalar and ankle fusions.
“Both the Mini-Rail and large Cannulated Screw 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,” Anthony G. Viscogliosi, chairman and CEO of SBi, stated in the release.
- Reference:
www.totalsmallbone.com
