(22 days)
The TOWNLEY Pedicle Screw Plating System is intended to stabilize the spine as an aid to fusion. After first making drill holes in the pedicles, a DYNA-LOK® Plate is positioned over the pedicles. TOWNLEY Pedicle screws are then inserted through the plate, down the center of the pedicles, and into the vertebral body. Bone graft must be used with each procedure.
This system is indicated for the treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: (a) Trauma, including spinal fractures and/or dislocations, (b) Spondylolisthesis, all grades and types, (c) Spondylolysis, (d) Pseudarthrosis, (e) Degenerative disc disease and/or degenerative diseases which include: (1) 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 (2) degenerative disease of the facets with instability.
For all these indications, bone graft must be used and the system is limited to screw fixation from C2 to S1.
This system consists of a broad-headed, partially threaded screw designed to compress bone grafts. Screw lengths range from 0.5 to 2.5 inches. Both cortical and cancellous screw threads are available. The screw comes in two configurations: flat-head or hex. The hex screws are wider in diameter. The DYNA-LOK® plates are used to interconnect two or more vertebrae together via screw fixation through the pedicles. The components are made of titanium alloy such as described by ASTM F-136. or ISO 5832-3. Alternatively, the entire system may be made out of medical grade stainless steel such as described by ASTM F-138 or ISO 5832-1 or ISO 5832-9. This 510(k) submission seeks to add the titanium alloy components to the TOWNLEY Pedicle Screw Plating System.
This document describes the TOWNLEY Pedicle Screw Plating System but does not contain information regarding acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) summary from 1998, focused on demonstrating substantial equivalence to a predicate device. For medical devices, "substantial equivalence" means that the new device is as safe and effective as a legally marketed device (the predicate). This typically involves comparing features, materials, indications for use, and performance data, often relying on existing data or widely accepted engineering principles rather than a new clinical study with specific acceptance criteria in the way a clinical trial for a drug or a novel AI software might.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study as the provided text does not contain that information. The document explicitly states:
"Documentation was provided which demonstrated the TOWNLEY Pedicle Screw Plating System to be substantially equivalent to itself."
This phrase, while perhaps unusual in its wording ("to itself"), implies that the submission focused on changes to an existing device already on the market (in this case, adding titanium alloy components to a system previously described). The FDA's response confirms that the device is "substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified." This reaffirms the focus on equivalence rather than meeting new, specific performance metrics from a dedicated study.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.