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Home » In2Bones wins FDA nod for 2 foot repair systems

In2Bones wins FDA nod for 2 foot repair systems

August 8, 2017 By Fink Densford

In2Bones

French orthopedic surgical device developer In2Bones said today that its US subsidiary received FDA clearance for its 5MS Fracture repair and CoLag locking compression screw systems.

The company’s 5MS fracture repair system is a plate and screw system designed to treat fractures and deformities of the 5th metatarsal bone and features an array of anatomically contoured plates and fracture-specific screws.

“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,” Dr. Kevin Varner of Houston Methodist Orthopedics and Sports Medicine said in prepared remarks.

The CoLag locking compression system features differential, dual-pitch screw threads and a low-profile head to lock between bone fragments and fractures and improve compression.

“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 1 of the most significant advances in screw fixation in the past 25 years,” Dr. Keith Heier said in a prepared release.

Both systems are provided in individualized, pre-sterilized packaging, In2Bone said.

“At In2Bones, our goal is to advance the science of extremity surgery. Our development pipeline is robust and will provide growth opportunities for us around the world,” prez & CEO Alan Taylor said in a prepared statement.

Filed Under: Food & Drug Administration (FDA), Orthopedics, Regulatory/Compliance Tagged With: In2Bones

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