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The XIA® 4.5 Spinal System is intended for posterior noncervical pedicle fixation for the following indications: severe spondylolisthesis (i.e. Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The XIA® 4.5 Spinal System is also intended for anterolateral and posterior, non-cervical, nonpedicle fixation for the following indications: degenerative disc disease (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 XIA® 4.5 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients only.

The Stryker Spine Xia" 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial bone screws, Blockers, Hooks. Dual Staples, and Connectors. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants are provided non-sterile and are used for either posterior or anterolateral non-cervical spinal fixation.

This submission is intended to address a line extension to Xia" 4.5 Spinal System. The line extension includes a new range of Titanium alloy connectors.

This submission is a 510(k) premarket notification for a line extension to an existing spinal system. It does not describe a study involving an AI/ML device or its performance characteristics. Instead, it focuses on demonstrating substantial equivalence to a predicate device for a modified medical implant. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not applicable to this document.

The document describes the:

• Identification of the device and sponsor.
• Description of the device modification: A line extension including a new range of titanium alloy connectors for the Xia® 4.5 Spinal System.
• Intended Use: Specifies the indications for both posterior noncervical pedicle fixation and anterolateral and posterior, non-cervical, non-pedicle fixation, for skeletally mature patients only.
• Statement of Technological Comparison: Asserts that the new components share the same intended use, material, and basic design concepts as the predicate device (Xia® 4.5 Spinal System, K050461). It also states that "Mechanical testing also demonstrated comparable mechanical properties to the predicate device." This is the only mention of "testing" and it refers to mechanical properties, not clinical or algorithmic performance.
• FDA's substantial equivalence determination letter: Confirming the device is substantially equivalent to legally marketed predicate devices.

In summary, there is no clinical study or AI/ML device performance evaluation presented in this document. The submission is for a modification to a spinal implant and relies on demonstrating substantial equivalence through material, design, intended use, and mechanical properties.

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