First 3D Expandable Interbody System Cleared by FDA

July 1, 2017 3D Printing, FDA, Orthopedics, Spine

K2M Group Holdings, Inc. stakes claim to be the first leading spine company to market a 3D-printed titanium interbody device. Now the company is adding to its portfolio after receiving 510(k) clearance for its MOJAVE PL 3D Expandable Interbody System.

That clearance, according to a June 22, 2017 company announcement, allows the company to be the first-to-market with an FDA-cleared, 3D-printed expandable posterior-lumbar (PL) interbody system. The company also said it offers the most comprehensive portfolio of 3D-printed spinal devices.

The fusion device features K2M’s Lamellar 3D Titanium Technology and is designed to allow for independent control of the anterior and posterior height in the lumbar spine. The company says this is a new capability not available with any other product in the market today. Featuring infinite adjustment within the expansion range, the implant may be locked at any desired height and lordosis to aid in the restoration of sagittal balance.

Steven Ludwig, M.D., an orthopedic spine surgeon and professor of orthopedics at the University of Maryland Medical Center in Baltimore says the ability to provide independent control of both the anterior and posterior height separately “is desirable for the restoration of sagittal balance compared to existing devices that can’t independently adjust both anterior and posterior height.”

By Walter Eisner | Orthopedics This Week

Image Credit: K2M

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About Peter Coffaro 605 Articles

A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the medical device industry. As a District Sales Manager for Stryker Orthopaedics, Peter was responsible for managing and directing a regional sales force to achieve sales and profit goals within the Rocky Mountain region. Previously, he was the Director of Sales & Marketing for Amp Orthopedics. In this role, Peter was responsible for planning, developing, and leading all sales and marketing initiatives. Peter is a former orthopedic distributor in the Pacific Northwest. He has also worked with DePuy Orthopaedics as well as Zimmer, and held positions in sales, sales training, and sales management. Peter has an extensive background in organizational development, business development, sales management, negotiating and P&L management. Peter holds a B.S. degree in Biology from Northern Illinois University.