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The Posterior Lumber System Multi-Axial Screw DESCO is a posterior, nonpedicle screw system of the noncervical spine indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, tumor, pseudoarthrosis, and failed previous fusion. The Posterior Lumbar System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis). The Posterior Lumbar System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to Sacrum) with removal of the implants after the attainment of a solid fusion.

The crosslinks and rod-to-rod connectors are used to connect two rods in a pedicle screw construct. The purpose is to add further stability to the system. The components are made of medical grade, FDA recognized, titanium alloy (ASTM F316). The rigid crosslinks come in sizes ranging from 15mm to 48mm, in increments of 3mm, and the modular crosslinks come in 3 sizes (small 30-38mm, medium 37-52mm, and large 50-70mm), but can lock at any size in between the ranges. The variable flat crosslinks contain 2 components an SX (left) and DX (right). The two are connected by a nut that can lock the connector along any length: small 26.6-33.6mm, medium 36.6-53.6mm, and large 46.6-73.6mm. The cross-links are used to connect parallel constructs along the spinal column to stabilize the system. The rod-to-rod connectors come in domino form and longitudinal. The rod-to-rod connectors will connect two rods in series either along the same axis by utilizing the longitudinal connector or offset the rod laterally by approximately 5.5mm (the diameter of a rod) utilizing the domino connector. The crosslinks and rod-to-rod connectors utilize a nut which threads through the component and comes to contact with the rod to lock the component to the rod along the construct.

The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF spinal system is to be used with the anterior lateral plate that is included in the system, and may also be used with Sintea Biotech's PLS Spinal System. Additionally, the DSC/ALF spinal system is intended to be used with autograft.

This 510(k) consists on the submission to add additional lengths and cross-sections, an improved locking mechanism, cage body redesign, and end-plate charges to a previously cleared system. The DSC/ALF Spinal System provides two basic components: A VBR (DSC) and an anterior lateral fixation plate (ALF). The DSC has a hollow internal module that can slide in relation to an external module, which enables the former to be locked in the most suitable position by means of two screws. These screws are inserted into two tooth rails on the internal cage, on both the anterior and posterior part, and mechanically lock the two modules. Both modules have endplates that optimize the contact with the vertebral bodies between which the device is inserted, thus ensuring better primary stability. The cages present a symmetrical geometry in order to make device placement simpler for the surgeon. The ALF is composed of two plates that connect to the anterior side of a vertebra by two screws. The two plates are connected by a rod. All components of the DSC/ALF Spinal System are made of medical grade titanium alloy (Ti-6Al-4V) as described by ASTM Standard F136.