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When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:

• degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• spondylolisthesis
• fracture
• spinal stenosis
• deformities (i.e. scoliosis, kyphosis, lordosis)
• tumors
• failed previous fusion (pseudoarthrosis)

The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:

• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion.

In addition, the PLUS Pivot Link Universal 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 neurologic impairment
• fracture
• dislocation
• scoliosis
• kyphosis
• spinal tumor
• failed previous fusion (pseudoarthrosis)

The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel, manufactured according to ASTMs F138 and F1586.

The provided text does not contain information about acceptance criteria for a device, nor does it describe a study proving a device meets such criteria. Instead, it is a 510(k) summary of safety and effectiveness for a spinal instrumentation system.

The document focuses on:

• Device Description: The components of the PLUS™ Pivot Link Universal System (hooks, screws, rods, connectors).
• Indications for Use: The specific spinal disorders and conditions the system is intended to treat, both as a posterior, non-pedicle system and as a pedicle screw system.
• Basis of Substantial Equivalence: A statement that the device is similar in design, material, and indications to other FDA-cleared spinal instrumentation systems, with mechanical testing performed to demonstrate equivalence.
• FDA Clearance Letter: The formal letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because that information is not present in the provided text.

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