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The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

The Genesys Spine Binary® Anterior Cervical Plate System components are temporary implants used to stabilize the cervical spine during the development of a solid spinal fusion in patients with degenerative disease, trauma (including fractures), and tumor pathology.

The Genesys Spine Binary® Anterior Cervical Plate System consists of multi-segmented titanium/nitinol bone plates of various sizes and lengths, titanium bone screws in various diameters and lengths, and associated instrumentation. Fixation is provided by the insertion of bone screws into the anterior surface of adjacent cervical vertebrae. Fixation of the screws to the plate is accomplished by seating into the screw securement mechanism.

This document is a 510(k) premarket notification from the FDA, granting clearance for the Genesys Spine Binary® Anterior Cervical Plate System. This type of document is for medical devices and does not typically include detailed performance studies with acceptance criteria as would be found for software or AI medical devices. It focuses on demonstrating "substantial equivalence" to a legally marketed predicate device.

Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not present in this document.

The document states:

"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

And under "CONCLUSION":

"The overall technological characteristics have led to the conclusion that the additional implantable devices in the subject submission do not create a new worst case. As a result, the modified Genesys Spine Binary® Anterior Cervical Plate System is considered substantially equivalent to the previously cleared Genesys Spine Anterior Cervical Plate II System (Genesys Spine - K133245)."

This means the acceptance criterion is substantial equivalence to a predicate device, not performance against a set of statistical metrics from a clinical study for a new device. The "study" proving this is the 510(k) submission itself, where the manufacturer provides information comparing their device to the predicate device in terms of indications for use, technological characteristics, and safety and effectiveness.

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