K2M’s Mojave posterior lumbar (PL) 3D expandable interbody system has received 510(k) clearance from the US Food and Drug Administration (FDA). According to a company release, Mojave PL 3D is a first-to-market, 3D-printed expandable posterior-lumbar (PL) interbody system that features K2M’s Lamellar 3D titanium technology.
The clearance news comes just two days after the introduction of K2M’s Sahara anterior lumbar (AL) expandable stabilisation system.
The system is a fusion device designed to allow for independent control of the anterior and posterior height in the lumbar spine, a new capability, the release sates, that is 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.
“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 cannot independently adjust both anterior and posterior height,” says Steven Ludwig, an orthopaedic spine surgeon and professor of orthopaedics at the University of Maryland Medical Center in Baltimore, USA.
K2M’s Lamellar 3D titanium technology uses a 3D-printing method to create structures impossible with traditional manufacturing techniques. Starting with a titanium powder, the Mojave PL 3D endplates are manufactured through the selective application of a high-energy laser beam, incorporating complex internal geometries and rough surface architecture that pre-clinical data have associated with bone growth activity. Lamellar 3D titanium technology incorporates a porous structure along with rough surfaces to allow the potential for bony integration throughout the endplates.