DeGen Medical Latitude-C AM Cervical Interbody Fusion System

The DeGen Medical Latitude-C AM™ Cervical Interbody Fusion System is an additively manufactured anterior cervical interbody spacer for spinal fusion procedures at one or more cervical spine levels (C2-T1) in skeletally mature patients with degenerative disc disease. It is used with autograft or allograft bone and supplemental fixation, and patients must have undergone at least six weeks of non-operative treatment before implantation.

The primary difference from the predicate device is that the subject device implants are additively manufactured (3D printed) while the predicate device implants are subtractively manufactured (machined). Both share identical intended use, indications, design, function, and technology. The device features porous superior and inferior endplate surfaces and a central aperture for bone graft constraint, available in lordotic, anatomic, and symmetric configurations, manufactured from Puri-Ti™ unalloyed titanium.

ASTM F2077 (static and dynamic compression, compression shear, and torsion testing); ASTM F2267 (subsidence testing); ASTM F1877 (mass loss characterization); expulsion testing per Class II Special Controls Guidance Document for Intervertebral Body Fusion Devices (June 12, 2007).