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The TranS1® Facet Screws are to be used in conjunction with the TranS1® AxiaLIFTM System which includes the TranS1® 3D Axial Rod™, in order to create an anterior/posterior fixation construct as an aid to fusion.

The AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIFTM System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor, or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed facet and pedicle screw systems.

The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process.

The TranS1® Facet Screws are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3 or ASTM F-138 Stainless Steel.

The provided document is a 510(k) summary for the TranS1® Facet Screws, which aims to demonstrate substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing.

Instead, the submission focuses on establishing substantial equivalence based on:

1. Intended Use and Indications for Use: The document clearly states the intended use of the TranS1® Facet Screws in conjunction with the TranS1® AxiaLIFTM System for spinal fusion, including specific conditions they are indicated to treat and those they are not.
2. Technological Characteristics: It mentions that the screws are made of medical-grade titanium alloy or stainless steel conforming to ASTM and ISO standards.
3. Comparison to Predicate Devices: The core of the submission is to demonstrate that the TranS1® Facet Screws are "substantially equivalent" to two predicate devices: the Medtronic Sofamor Danek Townley Transfacetpedicular Screw Fixation System (K003928) and the Sofamore Danek Transfacetpedicular Screw Fixation System (K953076). This equivalence is claimed for "intended use, level of attachment, materials, labeling, sterilization, and technological characteristics." The range of sizes is also stated to be identical to or a subset of the predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria, as such details are not present in the provided text. The 510(k) process for this device relies on demonstrating equivalence to existing legally marketed devices, rather than presenting a de novo study with specific performance acceptance criteria.

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