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The Solar-S™ PSI (Standalone) and Solar-A™ PSI (Non-Standalone) are lumbar interbody fusion devices intended for use at one or more levels of the lumbosacral spine (L1- S1) in patients with degenerative disc disease (DDD), disc herniation (myelopathy and/or radiculopathy), spondylolisthesis or retrolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Solar-S™ PSI and Solar-A™ PSI Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

When used with three (3) screws, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels.

When used with three (3) tusks, interbody devices must always be used with supplemental fixation and may be used at one or more levels.

Hyperlordotic interbody devices (≥20° lordosis) used with screws or tusks, must always be used with supplemental fixation, and may be used at one or more levels.

When used with supplemental fixation, all Solar-S™ PSI Spacers used with screws or tusks may be used at one or more levels.

These devices are intended to be used at one or more levels with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

Solar-M™ PSI Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis or retrolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Solar-M™ PSI Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

The Impulse™ PSI is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or more levels in the lumbosacral spine (L1-S1) as an adjunct to fusion. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The Impulse™ PSI is indicated to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and are intended to be used with supplemental fixation systems cleared for use in the lumbar spine. The device is to be used in patients who have had six months of nonoperative treatment.

The DeGen Medical Patient-Specific Implant (PSI) System is a series of patient specific lumbar interbody spacers intended for use in anterior (Solar™ PSI) or posterior / transforaminal (Impulse™ PSI) lumbar fusion procedures. The DeGen Medical PSI devices are comprised of a single component that is additively manufactured. The superior and inferior endplates feature a porous surface to mitigate subsidence and expulsion. Superior and inferior faces feature a central aperture to constrain bone graft. The Impulse™ PSI spacers are available in two configurations: Impulse™ PSI and Impulse™ PSI Hyperlordotic. The Solar™ PSI patient specific spacers are available in three configurations; Solar-S™ (integrated fixation), Solar-A™ (anterolateral, with integrated fixation), and Solar-M™ (monolithic, without integrated fixation).

The DeGen Medical PSI spacers are additively manufactured from Puri-Ti™ unalloyed titanium. The DeGen Medical Solar-S™ PSI and Solar-A™ PSI incorporate integrated fixation in the form of screws manufactured from Ti-6AL-4V ELI Alloy per ASTM F136 or tusks additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ PSI Lumbar Interbody Spacer must be used with three (3) integrated screws and the spacer must have ≤20° of lordosis to be considered for standalone use. All implants may include patient matched endplates when provided with an adequate CT scan.

The Impulse™ and Solar™ PSIs are designed individually for each patient using patient imaging data (X-Ray, MRI, CT). Variable dimensions include anterior and posterior heights, bone graft window, lordosis, coronal angle, length, and width. When provided with an adequate CT scan, implants may also include patient-matched endplates. All implants are provided in their final geometry and are not intended to be altered or reshaped at the time of surgery.

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