(30 days)
The TOWNLEY™ 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 TOWNLEY™ 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 TOWNLEY™ 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 DYNALOK® 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.
For both 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.
The TOWNLEY™ Transfacetpedicular Screw Fixation System consists of screws designed to compress bone grafts. The screws are fabricated from medical grade stainless steel described by such standards as ASTM F-138 or ISO 5832-1 or ISO 5832-9, or titanium alloy conforming to such standards as ASTM F-136 or ISO 5832-3. The screws may be used with or without DYNALOK plates. DYNALOK 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 process when the system is used for the second fixation method described below. Stainless steel and titanium implant components should never be used in the same construct. The purpose of this submission is to add a 4.0mm titanium cortical bone screw to the system.
The provided text describes a medical device, the TOWNLEY™ Transfacetpedicular Screw Fixation System, and its indications for use. However, it does not contain any information regarding acceptance criteria, study data, or performance metrics for the device.
The document is a 510(k) summary and letter from the FDA, confirming substantial equivalence to a previously marketed device (in this case, itself). This type of submission generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance studies against specific acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. All the requested information points (1-9) are missing from the document.
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