CAMBER SPINE TECHNOLOGIES ANNOUNCES FDA CLEARANCE AND NATIONAL LAUNCH OF SPIRA™ OPEN MATRIX ALIF 510(k) Clearance Marks Camber’s Tenth Spinal Product to Market
WAYNE, Pa., August 15, 2017 – Camber Spine Technologies announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPIRA™ Open Matrix ALIF device, a unique, interbody fusion implant consisting of spiral support arches and Surface by Design™ technology. This clearance marks Camber’s tenth line of spinal implant systems to be released in the US market.
SPIRA™ was designed specifically to increase fusion rates and stabilization. The spiral support arches decrease subsidence by load sharing over the entire endplate, while also maximizing bone graft capacity. The Surface by Design™ technology is a deliberately designed roughened surface that facilitates bone growth through an optimized pore diameter, strut thickness and trabecular pattern.
"Camber Spine is very excited to be launching our first in a series of spinal implants using 3D printed - additive manufacturing. This specialized manufacturing technology allows us to create these truly unique patented structures featuring open arched matrices and proprietary surfaces designed to enhance fusion and promote bone growth. In the coming months we will be launching a series of five SPIRA™ spinal interbody cages for cervical, lateral, and posterior lumbar spine. Extremity implants and custom implants for salvage and complex deformity implants are also under development.”
“We believe that the addition of SPIRA™ and ENZA™ MIS Integrated interbody devices to our product portfolio create a foundation of patented implant solutions that will drive the growth of Camber Spine".
-Daniel Pontecorvo, CEO Camber Spine The Camber Spine SPIRA™ Open Matrix ALIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. SPIRA™ Open Matrix ALIF is intended to be used with additional FDA-cleared supplementary fixation systems.