K2M receives 510(k) clearance from US FDA and CAYMAN

Image: www.k2m.com

K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, has announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and a CE Mark for its CAYMAN® United Plate System following completion of its first surgical cases. CAYMAN United is designed for rigid fixation to K2M’s CASCADIA™ Lateral 3D Interbody System featuring Lamellar 3D Titanium Technology™, the first and only 3D-printed cage with modular fixation capabilities.

The CAYMAN United Plate System’s single level, 1- and 2- hole plate configurations precisely match all CASCADIA Lateral 3D height and lordosis options, allowing surgeons to customize the construct using a lateral approach.

K2M’s Lamellar 3D Titanium Technology uses an advanced 3D printing method to create structures that are impossible with traditional manufacturing techniques.

Balance ACS® (or BACS®) provides surgical solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.