In2Bones Global, Inc. announced on August 8, 2017, that its In2Bones USA, LLC subsidiary has received FDA (510k) clearance for a new foot fracture and correction system. The system will be marketed under the 5MS Fracture Repair System and the CoLag Locking Compression Screw System brand names.
FDA Clearance for Foot Repair System
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The fracture repair system is a comprehensive plate and screw system that addresses both fractures and deformities of the 5th metatarsal bone (5th toe) of the foot. Unlike competitive systems, the company says their system features an array of anatomically contoured plates and fracture-specific screws that provides surgeons more options to customize the needed repair.
Kevin Varner, M.D. of Houston Methodist Orthopedics and Sports Medicine said fractures of the 5th metatarsal are the most common in athletes of all skill levels. “The 5MS System’s unique plantar fracture plate design may address many of the healing complications seen from other methods of treatment.”
The compression screw system, according to the company, is an entirely new concept in orthopedic bone fixation. “Differential, dual-pitch screw threads combined with a low-profile head create a compression lock between the bone fragment and fracture, significantly improving compression compared with competitive headless screws.”
Keith Heier, M.D., past president of OrthoTexas Orthopedics & Sports Medicine, said bone fragment stability and compression are important factors in healing. “The CoLag System creates the compression of current headless screws while offering the stability, fixation and ease of removal of screws with heads. This design may be one of the most significant advances in screw fixation in the past 25 years.”
In August 2016, In2Bones USA, LLC and In2Bones, SAS (Lyon, France) merged to form In2Bones Global, Inc., headquartered in Memphis, Tennessee. Since the merger, the company has launched several products including the NeoView PEEK Distal Radius Plate, the NeoSpan SuperElastic Compression Staple, the Reference Toe System, AlloAid PIP, AlloAid Nail and the CoLink Forefoot Plating System.
The company was launched in 2014 by former extremity company executives.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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