ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

The ZSFab Cervical and Lumbar Interbody Systems are additively manufactured (3D-printed) titanium alloy fusion devices designed to stabilize the spine and facilitate bone fusion. The cervical system treats disc degeneration and spinal instability in the neck (C2–T1) in skeletally mature patients after six weeks of conservative treatment, while the lumbar system addresses degenerative disc disease in the lower spine (L2–S1) after six months of conservative treatment. Both devices feature lattice structures and bone graft windows and are used with supplemental fixation and bone graft material.

The subject and predicate devices have identical technological characteristics including indications for use, structure and function, materials of manufacture (titanium alloy Ti-6Al-4V ELI per ASTM F3001), manufacturing process, biocompatibility, sterility, and available sizes. Both cervical and lumbar implants incorporate lattice structures with specified pore dimensions and endplates with teeth design, with no meaningful differences between subject and predicate devices.

ASTM F2077 dynamic axial compression, ASTM F2077 dynamic compression shear, and ASTM F2077 dynamic torsion testing were performed. The devices are manufactured per ASTM F3001 for titanium alloy specifications. Quality Management System Regulation (QMSR, 21 CFR Part 820) and ISO 13485 standards apply to manufacturing and design controls.

The subject devices are substantially equivalent because they have identical technological characteristics to the predicate devices (K242734 and K252610), including indications for use, structure, function, and materials. The submission represents an expansion of production to an additional 3D printer model, with mechanical performance data from ASTM F2077 testing confirming the subject devices perform equivalently to previously cleared devices without raising safety or efficacy concerns.