(97 days)
The CAPRI Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The CAPRI Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.
For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths and heights to match the patient's anatomy. Solid (titanium alloy) and adjustable (titanium alloy and cobalt chrome) cages are available and can be implanted via posterior, anterior or lateral approaches. The implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium alloy (per ASTM F3001) and Cobalt Chrome (per ASTM F1537).
Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.
This document is a 510(k) summary for the CAPRI Corpectomy Cage System, a medical device for vertebral body replacement. It details the device's intended use, classification, technological comparison to predicate devices, and non-clinical performance evaluation. It does not contain information about clinical acceptance criteria or studies with human subjects.
Therefore, I cannot provide the requested information, which pertains to clinical acceptance criteria, device performance on a test set, expert involvement, or human reader effectiveness studies. The document only describes non-clinical mechanical testing.
§ 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.