(130 days)
Indicated for use in anterior screw fixation to the cervical spine ( C2 - C7 ) for the following indications : degenerative disc disease ( DDD ), spondylolisthesis, trauma ( including fractures ), spinal stenosis and tumors ( primary and metastatic ), failed previous fusions (pseudarthrosis ) and deformity ( defined as scoliosis, kyphosis or lordosis ).
The Tectonic Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from Titanium Alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.
After reviewing the provided document, I cannot identify any information regarding acceptance criteria, device performance, results from a study, or details about ground truth establishment.
This document is a 510(k) Premarket Notification summary and approval letter for the Tectonic Cervical Plate System. It focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a detailed clinical study with specific performance metrics against pre-defined acceptance criteria.
The key points from the document are:
- Device: Tectonic Cervical Plate System
- Intended Use: Anterior screw fixation to the cervical spine (C2-C7) for various indications (degenerative disc disease, trauma, tumors, etc.).
- Comparison: The device is deemed "substantially equivalent" to predicate devices (Cervical Spine Locking Plate System, Codman Anterior Cervical Plate System, Blackstone Anterior Cervical Plate System) in design, function, material, and intended use. The document explicitly states: "There are no significant differences between the Tectonic Cervical Plate System and other systems currently being marketed which would adversely affect the use of the product."
- Regulatory Outcome: The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
Therefore, I cannot fulfill your request for the Acceptance Criteria, Reported Device Performance, Study Details, or Ground Truth information based on this document. Such information would typically be found in detailed clinical study reports, performance testing reports, or validation summaries, which are not part of this 510(k) summary.
§ 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.