E3D™-C Interbody System

The E3D™-C Interbody System is an intervertebral body fusion device designed for cervical spine fusion (C2-T1) in patients with degenerative disc disease, instability, trauma, deformity, spondylotic myelopathy, stenosis, or failed previous fusion. The devices are filled with autograft and/or allogeneic bone graft and come in Static (requiring supplemental fixation) and Integrated (used with screws or anchors) variants.

The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) using additive Direct Metal Laser Sintering (DMLS) 3D-printing per ASTM F3001, featuring a double lattice architecture to encourage bone growth. Integrated interbodies include two screw holes and an integral cam locking mechanism. Devices are available with or without HAnano Surface®, a 20–40 nanometer hydroxyapatite surface treatment. The submission adds three new footprint sizes (20×14mm, 20×16mm, 22×19mm) to previously cleared sizes.

ASTM F3001 (titanium alloy powder, additive manufacturing), ASTM F136 (titanium alloy for screws, subtractive manufacturing), ASTM F2077 (static and dynamic mechanical testing: compression, shear, torsion), ASTM F1877 (wear debris analysis), ASTM F2267 (expulsion and subsidence).

The proposed implants are identical to the primary predicate (K241846) in principle of operation, indications for use, stabilization method, anatomic location, approach, product code, classification, sterilization, material, and biocompatibility. The new footprints fall within the size range of an additional predicate (Alphatec K211805). Since no new worst-case geometry is introduced, prior mechanical testing on the predicate remains applicable, demonstrating substantial equivalence.