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ALLUMIN8® A8 INTEGR8™ porous pedicle screws are intended to immobilize and stabilize spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system to treat the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
2. Spondylolisthesis;
3. Trauma (i.e., fracture or dislocation);
4. Spinal stenosis;
5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
6. Spinal Tumor;
7. Pseudoarthrosis; and
8. Failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the ALLUMIN8® A8 INTEGR8™ porous pedicle screws are intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

ALLUMIN8® A8 INTEGR8™ Porous Pedicle Screws are intended to be used with autograft or allograft.

The A8 INTEGR8™ Porous Pedicle Screw System is a thoracolumbosacral pedicle screw system containing implants intended to provide immobilization and stabilization of spinal segments. The system consists of porous additively manufactured (AM) pedicle screws and machined polyaxial tulip assemblies and machined rods.

Immobilization and stabilization are achieved by connecting each spinal segment which have affixed pedicle screws with the spinal rods.

Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy. The pedicle screw shafts are made from Ti-6Al-4V ELI per ASTM F3001. All other implant components (tulips, saddle, locking ring, and rods) are machined.

The rods are offered in various diameters and lengths to accommodate individual patient anatomy. The rods are available in straight or pre-lordosed curvature to meet patient anatomical needs and are manufactured from either Ti-6Al-4V ELI or Co-28Cr-6Mo.

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