(26 days)
Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The ZEPHIR™ Anterior Cervical System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The ZEPHIR™ Plates include anti-migration caps that cover the heads of the bone screws to reduce the potential for screw back-out. The anti-migration caps come pre-assembled to the plate.
The purpose of this submission is to add additional screws to the Zephir™ Anterior Cervical System.
The provided text is a 510(k) summary for the Zephir™ Anterior Cervical System. It describes the device, its indications for use, and states that it has been found substantially equivalent to itself. This document is a regulatory submission for a medical device (a cervical plate and screws), which means it focuses on demonstrating safety and effectiveness based on equivalence to existing devices, rather than presenting a study of its performance against specific acceptance criteria in the way an AI/software device would.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic devices, are not applicable to this 510(k) submission.
This document indicates a substantive equivalence finding, meaning the FDA determined the device is as safe and effective as a legally marketed predicate device. This is a common pathway for medical device approval, particularly for physical implants or instruments, and does not typically involve the types of performance studies described in your request for AI/software validation.
§ 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.