(21 days)
The Retain Radiolucent Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Retain Radiolucent Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.
The Retain Radiolucent Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Retain Radiolucent Spacer is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has large open area to allow grafting material to be packed inside of the spacer. Ridges on the superior and inferior surfaces of each device help to grip the endplates of the adjacent vertebrae to resist expulsion.
The Retain Radiolucent Spacer devices are made from radiolucent polymer, titanium alloy and tantalum as specified in ASTM F2026, F136, F1295, and F560.
This request cannot be fulfilled. The provided text is a 510(k) summary for a medical device (Retain Radiolucent Spacer) and does not contain information typically found in a study describing acceptance criteria and device performance as requested.
Specifically, the document focuses on:
- Device Description: What the Retain Radiolucent Spacer is made of and its components.
- Intended Use: The medical conditions and anatomical locations for which the device is designed.
- Predicate Device: Its similarity to a previously cleared device (Sustain Radiolucent Spacer K040284).
- Regulatory Information: Classification, product code, and the FDA's clearance letter.
- Performance Data: It merely states "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 was presented." This does not provide specific acceptance criteria, reported performance values, or details about a study for proving these criteria.
Therefore, the requested information cannot be extracted from the provided text. A study report with detailed performance metrics, acceptance criteria tables, sample sizes, ground truth establishment, etc., would be needed to answer the prompt.
§ 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.