FIX-L PEEK PLIF and T-PLIF System

The FIX-L PEEK PLIF and T-PLIF System is an intervertebral body fusion cage device made of PEEK material with tantalum markers, designed for lumbar spine fusion in skeletally mature patients with degenerative disc disease and up to Grade 1 spondylolisthesis at one or two contiguous levels (L2-S1). It is used with autologous bone graft and supplemental fixation in patients who have failed six months of nonoperative treatment, and requires hospital sterilization via autoclave before use.

The device is made of PEEK VESTAKEEP i4R body (ASTM F2026) and tantalum markers (ASTM F560) for radiographic visualization. It comes in multiple sizes and configurations for both posterior lumbar interbody fusion (PLIF) and transforaminal posterior lumbar interbody fusion (T-PLIF) approaches to accommodate anatomical variation.

ASTM F2077 (static and dynamic axial compression testing, static and dynamic compression shear testing); ASTM F2267 (load-induced subsidence testing under static axial compression).

The device is substantially equivalent because it has identical intended use (intervertebral fusion with bone graft) and equivalent technological characteristics to the predicate devices (4CIS PEEK PLIF Cage and FIX-C PEEK Anterior Cervical Interbody System), including material composition, design approach, sterilization method, and biocompatibility. Bench testing demonstrated equivalent performance across mechanical testing standards without significant differences that would adversely affect product use.