X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System

The X-PAC® TLIF and LLIF Expandable Posterior and Lateral Cage Systems are lumbar interbody fusion devices made of titanium alloy designed to provide structural support following disc removal in patients with degenerative disc disease at one or two spinal levels (L2-S1). They are expandable cages with toothed surfaces and fenestrations to promote bone fusion, used with bone grafts or bone void fillers and supplemental fixation, intended for skeletally mature patients who have undergone at least 6 months of conservative treatment.

The subject devices are identical to predicate devices in intended use, materials (medical-grade titanium alloy per ASTM F136 and F1472), manufacturing processes, operating parameters, and instrumentation. Both feature toothed surfaces on upper and lower plates, fenestrated design for bony ingrowth, bulleted nose for disc entry, and intraoperative height adjustability. Differences in technological characteristics are stated as not expected to affect performance and safety.

ASTM F136 and ASTM F1472 cited as material standards for medical-grade titanium alloy manufacturing. No other specific test methods or consensus standards are detailed in this summary.

The applicant argues substantial equivalence based on device identity: the subject cages are identical in intended use, materials, manufacturing, operating parameters, and instrumentation to the previously cleared predicate devices (K223174 and K222797). Because the devices are identical, existing testing data from the predicates is deemed adequate to support expanded indications to include use of allograft and bone void filler. The submission is thus a special 510(k) for an indications expansion of an unchanged device.