(33 days)
The NuVasive™ Triad™ Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The NuVasive™ Triad™ Facet Screw System is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 for the 3.5mm screws, and from L1 to S1 for the 4.5mm screws. The Triad™ Facet Screw System is indicated for treatment of any or all of the following: (a) pseudoarthrosis and failed previous fusion; (b) spondylolisthesis; (c) spondylolysis; (d) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; (e) degeneration of the facets with instability; and (g) fracture. The NuVasive™ Triad™ Facet Screw System is intended for conventional or percutaneous surgical placement.
The NuVasive™ Triad™ Facet Screw System consists of broad-headed, partially threaded screws designed to compact juxtaposed facet articular processes to enhance spinal fusion The non-threaded portion facilitates compression of the joint surfaces and stability. through a lag technique. Washers may be used to complement the screws by helping distribute forces and maintain consistent contact area when the screws are angled relative to the bone surface. The screws and washers are fabricated from anodized titanium alloy (Ti-6Al-4V) and are supplied in various sizes.
This 510(k) Premarket Notification for the NuVasive Triad Facet Screw System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Instead, this document describes a Special 510(k) submission, which is used for modifications to a previously cleared device where the modifications do not raise new questions of safety or effectiveness.
Here's why the requested information is absent:
- Type of Submission: A Special 510(k) relies on the substantial equivalence to a predicate device that has already established its safety and effectiveness.
- "Summary of Clinical Tests (Not applicable.)": Section H explicitly states that clinical tests are "Not applicable." This indicates that no new clinical study was performed to demonstrate the device's performance against specific acceptance criteria.
- Reliance on Predicate and Design Controls: The submission states that "engineering drawings and labeling have demonstrated that the subject device is equivalent to the original device in terms of design, materials of composition, manufacturing, packaging, indications for use, and method of use, excepting only the fact that it may be implanted in conjunction with a washer, and may be available in a cannulated design in specific sizes." It further mentions "a comprehensive program of verification and validation activities demonstrating that acceptance criteria were met, and that design output satisfied design input." However, these "acceptance criteria" are likely related to engineering specifications and performance within the established design controls for the modified device, rather than clinical performance measured against specific metrics as would be expected for a novel device.
Therefore, I cannot provide the requested table or details about a study demonstrating the device meets acceptance criteria because such information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to its predicate device rather than presenting new performance data from a standalone study.
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