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The SKYLINE Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instabliity caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

The UNIPLATE Anterior Cervical Plate System and UNIPLATE 2 Anterior Cervical Plate System are intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kvphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.

The UNIPLATE and UNIPLATE 2 Anterior Cervical Plate Systems are also indicated for treatment of spinal stenosis.

The UNIPLATE® and UNIPLATE® 2 Anterior Cervical Plate Systems consist of an assortment of titanium alloy plates and screws. The anterior cervical plates are available in various lengths to accommodate one to three segments of fixation. The screws are available in various sizes and tip geometries.

The SKYLINE® Anterior Cervical Plate System consists of an assortment of titanium alloy plates and screws. The plates have two to six screw hole pairs in various lengths: The screws are available in various sizes and screw-tip geometries. Both constrained and variable screws are available to create a constrained, variable or hybrid configuration.

The provided text is a 510(k) summary for anterior cervical plate systems, focusing on demonstrating substantial equivalence to predicate devices, primarily due to a change in sterilization method. It explicitly states that "Performance data is not provided in this submission." Therefore, the document does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or results of MRMC or standalone studies.

This document is a regulatory submission for a medical device that has undergone a change in manufacturing process (sterilization method). The manufacturer is asserting that this change does not alter the fundamental safety or effectiveness of the device, and therefore, extensive new performance studies are not required. Instead, they are relying on the established performance and safety of the previously cleared predicate devices.

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