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The Degas Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Degas Anterior Cervical Plate System consists of a variety of shapes and sizes of main plates. screws, sub-plates, rivets and associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion.

The rivets are pre-assembled to the main plate, which firmly attach the sub-plate component to the main plate. Each component is color anodized to differentiate the screw type and diameter and to facilitate the surgical process.

The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are provided in fixed self-tapping, variable self-tapping, fixed self-drilling and variable self-drilling configurations.

The provided document K132366 is a 510(k) premarket notification for the Degas Anterior Cervical Plate System. This type of submission establishes substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through novel studies.

Therefore, the document explicitly states: "Non-clinical testing was not performed as part of this submission." This means that the information requested regarding acceptance criteria and performance studies for the Degas Anterior Cervical Plate System (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, ground truth type and establishment for test/training sets) is not available in this document.

The basis for clearance is that the subject device, the Degas Anterior Cervical Plate System, is identical to the previously cleared Rex System (K121862) in terms of:

• Indications for use
• Device dimensions
• Instrumentation
• Manufacturing process
• Cleaning/sterilization process
• Labeling

Therefore, the demonstration of safety and effectiveness relies on the prior clearance of the predicate device, not on new studies conducted for the Degas system.

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