Search Results

The TRANSFACETPEDICULAR Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods. The first fixation method uses the TRANSFACETPEDICULAR Screws as just facet fixation screws, where the screws are inserted bilaterally through the superior side of the facet, across the facet joint at (usually) a single level, and into the pedicle. In the second fixation method, the TRANSFACETPEDICULAR Screws are inserted bilaterally through the superior side of the facet, across the facet joint, and into the pedicle at multiple levels at the same time that a DYNA-LOK® Plate is attached to the base of the spinous processes at the corresponding levels with TRANSFACETPEDICULAR Screws. The second fixation method should be used when the spine has increased instability or multiple levels need to be fused. Bone graft must be used for both fixation methods.

This system is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

1. Trauma, including spinal fractures and/or dislocations.
2. Spondylolisthesis.
3. Spondylolysis.
4. Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity.
5. Degenerative diseases which include:
   (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or
   (b) degenerative disease of the facets with instability.

This system consists of a broad-headed, partially threaded screw designed to compress bone grafts. Both cortical and cancellous screw threads are available. The stainless steel DYNA-LOK® Plates are used as spinous process plates to connect two or more screws together on one side of the spine at the base of the spinous processes when the system is used for the second fixation method described below. All components are fabricated from medical grade stainless steel (ASTM F-138 or its ISO equivalent).

This document is a 510(k) summary for a medical device (TRANSFACETPEDICULAR Screw Fixation System) and describes the device, its indications, and the basis for its substantial equivalence claim. It does not contain information about acceptance criteria, study performance, sample sizes, expert qualifications, or ground truth establishment relevant to the performance evaluation of a device using AI or statistical analysis described in your request.

The provided text focuses on:

• Device Description: What the screw fixation system is made of and how it functions.
• Indications for Use: The specific medical conditions and spinal levels for which the device is intended.
• Basis for Substantial Equivalence: It states that "Literature and other documentation concerning this device system were supplied in support of establishing a claim of substantial equivalence and the preamendment status of a predicate device system."

Therefore, I cannot extract the requested information to fill your table and answer your questions because the document does not contain data from performance studies in the way you're asking. It predates the widespread use of AI in medical devices and the type of performance evaluation studies you're describing.

Ask a specific question about this device