In2Bones USA Announces FDA Clearance on Two Key Implant Systems

MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announced that its In2Bones
USA, LLC
subsidiary has received U.S. Food and Drug Administration
(FDA) clearance for its new Fracture and Correction System. The System
will be marketed under the 5MS™
Fracture Repair System
and the CoLag™ Locking Compression Screw
System brand names.

The 5MS 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 5MS System features an array of anatomically contoured
plates and fracture-specific screws that provides surgeons more options
to customize the needed repair.

The new System offers surgeons multiple design and performance
improvements compared with traditional plate products, plus the
versatility of interchangeable screws and plates, and specially designed
surgical instruments – all to enhance surgical technique and treatment
efficacy.

“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,” says Kevin
Varner, M.D.
of Houston
Methodist Orthopedics and Sports Medicine
.

The CoLag Locking Compression Screw System is an entirely new
concept in orthopaedic 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.

“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,” says Keith
Heier, M.D.,
Past President of OrthoTexas
Orthopedics & Sports Medicine
. “This design may be one of the
most significant advances in screw fixation in the past 25 years.”

As is true with all In2Bones USA products, the 5MS and CoLag implants
are delivered in individual, pre-sterilized packaging, and are UDI
compliant and fully traceable.

The past twelve months have been busy for the company. In August 2016,
In2Bones USA, LLC and In2Bones,
SAS
(Lyon, France) merged to form In2Bones Global, Inc., a Delaware
corporation headquartered in Memphis. Since the merger, and in addition
to these two new Systems, the company has launched several innovative
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.

“At In2Bones, our goal is to advance the science of extremity surgery,”
says Alan Taylor, President and CEO of In2Bones Global. “Our development
pipeline is robust and will provide growth opportunities for us around
the world.”

For more information about In2Bones Global, Inc. extremity products in
the U.S., please contact 844.602.6637, or visit www.i2b-USA.com.
In France, visit www.In2Bones.com.

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