(143 days)
The Stryker Spine AVS™ TL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant.
The Stryker Spine AVS™ TL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ TL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).
The Stryker Spine AVSTM TL Peek Spacer inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in thesurgical correction and stabilization of the spine. The construct is intended for use with supplemental fixation. The device is manufactured from Polyetheretherketone (PEEK) OPTIMA LT1 as described by ASTM F-2026-02. The three (3) Tantalum markers used for this product are made to the standard of ASTM F-560.
The provided text describes a medical device, the Stryker Spine AVS™ TL PEEK Spacer, and its clearance process through a 510(k) premarket notification. However, it does not contain information regarding acceptance criteria, performance data, or a study report in the format typically used to demonstrate a device meets specific performance criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against predefined acceptance criteria for a novel device. The document states:
"Documentation was provided which demonstrates the Stryker Spine AVS™ TL PEEK Spacer to be substantially equivalent to its predicate devices in terms of its material, sizes, and indications for use. Testing to demonstrate compliance with FDA's Guidance 'Spinal System 510(k)s', May 3, 2004 was completed for the Stryker Spine AVSTM TL PEEK Spacer."
This indicates that testing was conducted to show compliance with FDA guidance for spinal systems, likely related to mechanical properties, biocompatibility, and other relevant engineering standards, to support the claim of substantial equivalence. However, the specific results of this testing, detailed acceptance criteria for those tests, and information about the study design (like sample size, ground truth, expert qualifications, etc.) are not provided in the given text.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The document confirms that testing was done, but does not present the outcomes or the detailed methodology of those tests.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.