(29 days)
The Stryker Spine Vertebral Body Support System implant is a device intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (FI-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra due to tumor or trauma (i.e. fracture). For both corpectomy and vertebrectomy procedures, the Stryker Spine Vertebral Body Support System is intended to be used with supplemental internal spinal fixation systems. The use of bone graft with the Stryker Spine Vertebral Body Support System is optional.
The Stryker Spine Vertebral Body Support System consists of a cage body and endcaps.
The provided document is a 510(k) summary for a medical device (Stryker Spine Vertebral Body Support System) and does not contain the detailed study information required to answer the questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
This document primarily focuses on establishing substantial equivalence to a predicate device (Surgical Dynamics Mesh Cage System) for regulatory clearance. It states that "Performance data were submitted to characterize the additional components and design modifications," but it does not present those performance data or the specific acceptance criteria used for the study.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer questions 2 through 9 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.