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The Xia Spinal System and Xia 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The 6 mm diameter rods from the DIAPASONTM Spinal System and OPUSTM Spinal System are intended to be used with the other components of the Xia Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.

The Xia® Spinal System contains the same Stainless Steel and Titanium alloy components described in the predicate Xia® Spinal System submission cited above. The Xia® 4.5 Spinal System contains the same Titanium alloy components described in the predicate Xia® 4.5 Spinal System submission cited above. This submission adds an additional indication statement, but no new components.

The provided document is a 510(k) summary for the Stryker Spine Xia® and Xia® 4.5 Spinal Systems. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, performance studies, or clinical trial data as requested in your prompt.

Therefore, I cannot provide the requested information from this document. The document primarily discusses:

• Device Description: The Xia® and Xia® 4.5 Spinal Systems contain Stainless Steel and Titanium alloy components and are adding an additional indication statement.
• Intended Use: Anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation for specific spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Predicate Devices: Stryker Spine Xia® Spinal System (K053115), Stryker Spine Xia® 4.5 Spinal System (K052761), Medtronic Sofamor Danek's CD Horizon System (K032033).
• Technological Characteristics: Compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed.
• FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices.

This type of submission typically relies on non-clinical performance data (e.g., mechanical testing, biocompatibility) to demonstrate equivalence rather than a human-in-the-loop clinical study with experts establishing ground truth, as would be common for AI/diagnostic devices.

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