(495 days)
The CASSATT™ SU Fixation System is intended for fixation of sacroiliac joint disruptions and intended for sacrolliac joint fusion for conditions including.
· Sacroiliac joint disruptions,
· Degenerative sacroiliitis,
· To augment immobilization and stabilization of the sacroillac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The CASSATT™ SIJ Fixation System is a cannulated screw system, including head washer. The system offers various sizes to accommodate a wide range of anatomies. These devices come in various sizes to accommodate patient anatomy, which are all manufactured from titanium alloy, as specified in ASTM F136.
The provided text is a 510(k) Summary for the CASSATT™ SIJ Fixation System. This document outlines the rationale for the device's substantial equivalence to previously cleared devices. It does not describe an AI/ML powered medical device, therefore, the requested information about acceptance criteria, study that proves device meets acceptance criteria, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, ground truth, and training set information is not applicable.
The document focuses on the mechanical performance of a medical implant and compares it to predicate devices based on established ASTM standards.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.