CONDUIT™ SYNFIX™ Evolution Secured Spacer System

The CONDUIT SYNFIX Evolution Secured Spacer System is an anterior lumbar interbody fusion device consisting of a titanium cage and plate with integrated screws. It is indicated for single or two-level degenerative disc disease (L2–S1) with up to Grade I spondylolisthesis, can be packed with autograft, and requires supplemental fixation if used with fewer than four screws or for hyperlordotic implants exceeding 20 degrees.

The device uses 3D-printed Ti-6Al-4V ELI cages manufactured via selective laser melting with solid and porous structures, featuring a microscopically roughened surface with micro and nano-scale features on all surfaces including internal cell structures. The titanium plate (Ti-6Al-4V per ASTM F136) and bone screws (Ti-6Al-7Nb) employ a tapered-thread locking mechanism to secure the four screws to the plate.

ASTM F3001 (titanium powder bed fusion), ASTM F2077-24 (static and dynamic axial compression and shear), ASTM F2267-24 (subsidence), ASTM F2052-21 (magnetic displacement), ASTM F2213-17 (magnetic torque), ASTM F2119-24 (MR artifact), ASTM F2182-19e2 (RF-induced heating), ASTM F136 (plate titanium), and ISO 5832 (screw titanium).

Substantial equivalence is established through identical intended use (anterior lumbar interbody fusion for DDD), same technological approach (3D-printed titanium with integrated fixation), comparable mechanical performance (meeting established ASTM test criteria), and equivalent materials and manufacturing processes to the primary predicate (Synthes SYNFIX Evolution). No clinical data was deemed necessary because the design, indications, materials, and performance characteristics mirror those of legally marketed predicates.