(30 days)
The ORION® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The ORION® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy and may be supplied either sterile or non-sterile. The purpose of this 510(k) is to include modified screws to the ORION® Anterior Cervical Plate System.
The provided text is a 510(k) summary for the ORION® Anterior Cervical Plate System, focusing on the inclusion of modified screws into an existing system. This document is a regulatory submission for a medical device and describes its intended use and claims of substantial equivalence to a predicate device.
It does not contain any information regarding clinical studies, acceptance criteria for device performance (such as sensitivity, specificity, or accuracy), sample sizes for test or training sets, expert qualifications, or details about ground truth establishment.
Therefore, I cannot populate the table or answer the questions related to acceptance criteria and study details based on the provided text. The document focuses on regulatory approval based on equivalence to a previously cleared device, not on new clinical performance data from a standalone study.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.