(59 days)
The SynFixTM-LR is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedure due to tumor or trauma (i.e., fracture). The SynFixTM-LR is intended to be used with Synthes supplemental internal fixation systems, e.g. ATLP, TSLP, VentroFix or USS. The interior of the spacer component of the SynFixTM-LR can be packed with bone (autograft or allograft). SynFixTM-LR is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Synthes SynfixTM-LR is a combination radiolucent and radiopaque vertebral body replacement device to provide structural stability in skeletally mature individuals following corpectomy. The SynfixTM-LR may be used to accommodate the anatomical requirements of the space created by the corpectomy. Four screws are inserted through the anteriorly located plate into the neighboring vertebral bodies and lock securely to the plate using a tapered thread locking mechanism. The SynFixTM-LR is intended to be used with Synthes supplemental internal fixation systems, e.g. ATLP, TSLP, VentroFix or USS. The interior of the spacer has openings that can be packed with bone (autograft or allograft). The SynfixTM-LR is available as assembled components in various heights and geometrics to suit the individual pathology and anatomical conditions.
This document is a 510(k) summary for the SynFixTM-LR, a spinal intervertebral body fixation orthosis. As such, it does not contain any information about acceptance criteria or specific studies proving device performance against such criteria.
The document states that substantial equivalence was demonstrated based on comparison to a previously cleared vertebral replacement device (K011037). This typically means that the new device has similar technological characteristics and comparable performance to the predicate device, but specific performance metrics and acceptance thresholds are not provided in this summary.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, MRMC studies, or standalone performance for the SynFixTM-LR based on the provided text.
§ 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.