PRADO™ Lumbar Interbody Fusion System

The PRADO™ Lumbar Interbody Fusion System is an intervertebral body fusion device made from PEEK or hydroxyapatite-filled PEEK. It is indicated for skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2-S1, used with supplemental fixation and bone graft to facilitate spinal fusion. The device can also be used as an adjunct in multilevel degenerative scoliosis and sagittal deformity cases.

The PRADO device expands the shape, size, and lordotic angle options compared to the predicate InFront device. Additional changes include offering sterile packaging, using either tantalum or titanium rods as radiological markers, and optionally using hydroxyapatite-filled PEEK as the interbody material. The fundamental design—including ridged superior/inferior surfaces, lateral fenestrations, and threaded insertion holes—remains unchanged from the predicate.

Testing was performed according to ASTM F2077-18 and ASTM F2267-04, including static compression, dynamic compression, expulsion, and subsidence testing. Marker materials conform to ASTM F560 (tantalum) and ASTM F136 (titanium).

The fundamental scientific technology and mechanism of action are identical to the previously cleared InFront predicate device. Engineering analysis was performed to confirm that the expanded size range, shape variations, and lordotic angle options do not present new worst-case scenarios. The material and design changes (sterile packaging, marker options, HA-PEEK material) are incremental modifications that do not alter the device's fundamental function or safety profile.