ProLift Expandable Spacer System

The ProLift Expandable Spacer System is an intervertebral body fusion device made from titanium alloy that expands from 8mm to 16mm in height. It is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease at one or two contiguous lumbar levels (L2-S1), used with autograft or allogeneic bone graft and supplemental internal spinal fixation systems. The device features teeth on superior and inferior surfaces to prevent rotation and migration.

The device is fabricated from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136, the same material used in predicate devices. It is available in a range of sizes and footprints with expandable height capability. The mechanical performance characteristics remain unchanged compared to the predicate systems, with the worst-case performance scenario remaining identical.

ASTM F136 is cited for titanium alloy (Ti-6Al-4V ELI) material specification.

The ProLift Expandable Spacer System demonstrates substantial equivalence because it maintains identical indications for use, design, function, and materials to the predicate devices (K190488, K212520, K223430). The mechanical performance comparison analysis shows no change in performance characteristics, with worst-case scenarios remaining the same as the predicates. The device uses the same titanium alloy material and maintains the same expandable spacer design and sizing approach.