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The intended use of the Mariner Pedicle Screw System is to provide immobilization 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.

The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions 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,

• spondylolisthesis,

• trauma (i.e., fracture or dislocation),

• spinal stenosis,

• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).

• spinal tumor,

• pseudoarthrosis, and/or

• failed previous fusion.

The Mariner Pedicle Screw System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants including fixed, polyaxial, cephalad/caudal restricted-motion, and medial/lateral restricted motion pedicle screws as well as connecting spinal rods and a separate locking element.

The Mariner implants are manufactured from titanium alloy Ti-6Al-4V ELI (per ASTM F136), and cobalt chrome (Co-35Ni-20Cr-10Mo per ASTM F562 and Co-28Cr-6Moalloy 1 (warm worked) per ASTM F1537). The instruments included in the Mariner Pedicle Screw system facilitate the placement, removal, adjustment, and final locking of the system implants. Other accessories to the system also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

This document is a 510(k) summary for the SeaSpine Mariner Pedicle Screw System and does not contain information about the acceptance criteria or a study proving the device meets that criteria. The relevant sections explicitly state:

• "Non-Clinical Testing": "The SeaSpine Mariner Pedicle Screw System demonstrated similar performance to the predicate systems through static and dynamic mechanical testing with reference to ASTM F1717 and ASTM F1798." This indicates performance similarity to predicates based on established engineering standards but does not define specific acceptance criteria or report performance data.
• "Clinical Testing": "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This confirms that no clinical studies were performed to establish performance against acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. The document is primarily focused on demonstrating substantial equivalence to predicate devices, not on proving performance against a specific set of acceptance criteria through a dedicated study.

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