ExtremitiesRegulatory

In2Bones Receives FDA 510(k) Clearance for Quantum™ Total Ankle

February 06, 2020 

MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announces clearance from the U.S. Food and Drug Administration to market the Quantum™ Total Ankle.

This new total ankle replacement system treats patients who suffer from arthritis and is designed to improve patient mobility, increase stability, and technologically advance implant placement based on patient-specific anatomy.

Compared to current total ankles on the market, the anatomically designed talus with a dual radius of curvature improves the dorsi and plantar flexion of the patient. In addition, the Quantum system has a unique cruciate shaped vertical stem in the tibia to provide unsurpassed stability and fixation upon impaction.

The Quantum Total Ankle was designed with OrthoPlanify™ Patient Specific Instrumentation (PSI). Upon additional anticipated FDA clearances, it will be only the second total ankle on the market with this patient CT guided technology.

“There is a huge need for innovation in PSI for the total ankle, and the benefit to the surgeon and the patient with OrthoPlanify far exceeds what’s currently available to them,” says Jon Simon, Sr. Vice President of Marketing.

With OrthoPlanify, the surgeon controls the software to easily modify, adjust, and manipulate the views in their browser. In addition to the technologically advanced software, the 3D printed guides used in surgery save multiple steps and allow for precision bone cuts, compared to the predicate’s pin placement instruments.

In2Bones is set to initiate the controlled market release of the Quantum Total Ankle this summer, with a full market launch in the first quarter of 2021.

For more information about In2Bones Global, Inc. extremity products, please visit www.In2Bones.com.

About In2Bones

Headquartered in Memphis, Tennessee, In2Bones is a global 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.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

Media Contacts:
Jon Simon | Sr. Vice President of Marketing
In2Bones USA
6000 Poplar Ave, Suite 115 Memphis, TN 38119
O: 901.260.7931 • F: 844-712-6637
Email: jsimon@i2b-usa.com
https://www.linkedin.com/company/22344175/

Bob Reed
Element-R Partners
630.579.1770
bob@rurelevant.com

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Mike Adams

Mike Adams is a medical device sales leader with extensive clinical experience in spine and biologics and a nationwide distribution network built over the last 10+ years in the industry. He has held various leadership positions in healthcare and device including Distributor Partner, Hospital COO and Spine VP of Sales. He currently leads the commercialization strategy for OrthoSpine Partners and is a Distributor Principal at Novel Medical. Because of his unique career path, Mike has the ability to see the healthcare business from multiple perspectives making him passionate about building strategic partnerships that help reduce overall costs, drive innovation, and cultivate growth for new markets.

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