Search Results

IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. When used for these indications, the IB3D™ PL Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. All patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The IB3D™ PL Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. When implanting via posterior approach (PLIF), a minimum of two implants is required per spinal level.

The IB3D™ PL Spinal System implants are inter-somatic spacers manufactured by additive manufacturing (Direct Laser Metal Sintering) from Titanium alloy Ti-6Al-4V ELI powder, according to ASTM F3001 and ASTM F136. The IB3D™ PL Spinal System implants are intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach on the lumbar spine only. The subject IB3D™ PL Spinal System interbody devices are available in a variety of heights and lordosis angles for treatment of lumbar interbody fusion procedure. The implant is designed with a large hollow region in the center to house autograft or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The design incorporates hexalock macro-rough surface on the superior and inferior surfaces of the device along with angular teeth to prevent expulsion from the interbody space.