Search Results

The XIA® 4.5 Spinal System is 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 Stryker Spine DIAPASON™ Spinal System, OPUS™ Spinal System and XIA® Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector.

This 510(k) is intended to introduce an extension to the existing XIA® 4.5 Spinal System. The proposed line extension includes the addition of titanium Screws (monoaxial, polyaxial and reduction) and rod-to-rod connectors.

This document describes a 510(k) premarket notification for a line extension of the XIA 4.5 Spinal System. It is not a study that proves a device meets acceptance criteria through clinical or AI performance evaluation. Instead, it demonstrates substantial equivalence to existing predicate devices based on material, design, and indications for use. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and AI performance is not applicable to this submission.

Here's why and what the document does provide:

1. Nature of the Submission: This is a "Special 510(k) Premarket Notification" for a line extension to an existing Class III spinal system. The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive new clinical trials or performance studies involving algorithms.

2. Focus of the "Study": The document states: "Engineering analysis and testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 were completed for the systems." This refers to bench testing and engineering analysis (e.g., mechanical strength, fatigue, material compatibility) to ensure the new components (titanium screws and rod-to-rod connectors) meet established performance standards for spinal fixation devices and are comparable to the predicate devices. It is not a clinical study involving patients, or an AI performance study.

Therefore, the following requested information is not present or applicable in this 510(k) submission:

• Table of acceptance criteria and reported device performance (in the context of clinical or AI performance): The "acceptance criteria" here are likely mechanical and material specifications met through engineering tests against regulatory guidance, not clinical outcome metrics.
• Sample size for the test set and data provenance: No clinical test set involving human subjects or AI algorithms is described.
• Number of experts used to establish ground truth and qualifications: Ground truth in the context of clinical or AI performance is not applicable here.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was conducted or reported.
• Standalone (algorithm-only) performance: No AI algorithm is part of this device.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an engineering-focused 510(k).
• Sample size for the training set: No AI training set.
• How the ground truth for the training set was established: Not applicable.

What is present in the document related to "acceptance criteria" and "study":

• Acceptance Criteria (Implied - Regulatory & Engineering): The devices are substantially equivalent to predicates, meaning they meet the same safety and performance profiles as those devices. This is demonstrated through adherence to FDA guidance for spinal system 510(k)s, which would involve mechanical testing standards (e.g., fatigue, static bending), material biocompatibility, and sterilization validation. The "Indications for Use" statement also acts as a boundary for acceptance.
• Study (Type of "Study" Performed): "Engineering analysis and testing" were performed. This is typically bench testing (in vitro mechanical tests) rather than human clinical trials. These tests ensure the new components perform equivalently to the predicate devices and meet relevant ISO or ASTM standards for spinal implants.

Ask a specific question about this device