In2Bones Announces FDA Clearance of the CoLink® View “See-Through” Plating System (press release)
In2Bones Global, Inc. today announced that its In2Bones USA, LLC subsidiary has received U.S. Food and Drug Administration (FDA) clearance for an addition to its CoLink® Forefoot Bone Plating System used to stabilize bones during the post-surgical healing process. The addition will be marketed under the CoLink View brand name.
CoLink View Bone Plates incorporate a unique combination of titanium metal and a high-performance polymer called polyether ether ketone (PEEK). The CoLink View Plates include an X-ray transparent PEEK hub that allows the surgeon to literally watch the patient’s bone heal. This cannot be done with traditional metal plates because metal absorbs X-rays and blocks the image below. The “see-through” hub is unique to this new In2Bones plating system, and one of many device innovations designed by the company.
In addition to X-ray transparency, PEEK has a benefit of being less stiff than metal and more similar to the elasticity of bone. Bones need mechanical stress (elasticity) during the healing process. Stiffer, all metal implants may eliminate the positive elasticity and slow healing.
The CoLink View is the sixth In2Bones PEEK-related implant system that has received FDA clearance; others are expected to be cleared in 2018.
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 the aforementioned product, 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, the 5MS® fifth metatarsal fracture repair system, the CoLag® Screw System, an ankle fusion plate system and the PitStop™ PEEK subtalar implant.
For more information about In2Bones Global, Inc. extremity products in the U.S. and France, please visit www.i2b-USA.com or www.In2Bones.com.
# # #
About In2Bones USA, LLC
Located in Memphis, Tennessee, In2Bones USA, LLC is a designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. For more information, visit www.i2b-USA.com.
About In2Bones, SAS
Located in Lyon, France, In2Bones, SAS is a specialty orthopaedic company that develops and distributes upper and lower extremity products to enable surgeons to alleviate pain and restore motion for their patients. For more information, visit www.In2Bones.com.
Safe-Harbor Statement:
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current view of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” and other similar terms. The company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties impacting the business, including increased competition, technical obsolescence, regulatory issues, general economic conditions and other risks.
Contacts:
Susan Duensing, CBC
Element-R Partners
847.639.8300
[email protected]
