TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System

The TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System is an intervertebral fusion device intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease at one or two contiguous levels (L2-S1). The expandable titanium spacer (8–16 mm height) accommodates bone graft and connects to a lateral buttress plate system that provides supplemental fixation without load-bearing function.

The device is fabricated from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, the same material as predicate devices. It features superior and inferior tooth surfaces to prevent rotation and migration. The system is available in multiple sizes and footprints with expansion capability, and the buttress plate connects via set screw to the spacer.

ASTM F136 is cited for the titanium alloy material specification. No additional ISO, IEC, or other consensus standards are explicitly mentioned in the performance data or test methodology sections of this summary.

Substantial equivalence is established through material identity (Ti-6Al-4V ELI per ASTM F136), identical indications for use, and comparison analysis showing mechanical performance is unchanged from the predicate devices (Life Spine ProLift Lateral Expandable Cage System K221806 and Trulift Lateral Modular 1-Hole Buttress Plate K221806). The worst-case mechanical scenario remains the same, demonstrating design and functional equivalence.