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When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• Spinal Stenosis .
• Trauma/Fracture/Dislocation .
• Atlanto-Axial Fracture with Instability .
• Occipito-Cervical Dislocation .
• Failed Previous Fusion .
• Tumor .
  The use of occipital bone screws is limited to placement in the occiput only.
  The use of polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The purpose of this Special 510(k) is to add a modified screw configuration in multiple sizes. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.
The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.
The Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy and/or cobalt chrome alloy per ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

This document describes the Lanx Posterior Cervicothoracic Spinal Fixation System, which is a spinal fixation system that provides supplemental stabilization of spinal segments to support fusion. This submission is a Special 510(k) to add a modified screw configuration in multiple sizes. The device is substantially equivalent to a predicate device and is intended for use in the occipito-cervico-thoracic region of the spine in skeletally mature patients for various conditions.

Here's the information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device." This implies that the acceptance criteria for the modified device were to perform comparably to the previously-cleared predicate device in the specified mechanical tests. The specific quantitative thresholds for "substantial equivalence" or "functioned as intended" are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "Performance testing was conducted to characterize the modified components of the system. Tests were performed on the modified and predicate systems..." This implies a comparative test, but the number of units tested is not specified.
• Data Provenance: Not applicable in the context of device performance testing. The tests are experimental/laboratory-based, not based on patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is mechanical performance testing of a physical device, not an AI/software device that requires expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical performance testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes the mechanical performance testing of a spinal fixation system, not a study involving human readers or AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This document is about a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" is established by the standardized test methods outlined in ASTM F1717 and ASTM F1798. The performance of the predicate device serves as the benchmark against which the modified device's performance is compared to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device, not a machine learning model.

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