FIRST 3D EXPANDABLE INTERBODY SYSTEM CLEARED BY FDA (Orthopedics This Week)
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...
