(14 days)
The EBI® XFIX® Vision® Fixation System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
The System consists of external fixation components and implantable bone screws. The EBI® XFIX® Vision® Fixation System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue, and into the bone. The fixator frame of the EBI® XFIX® Vision® Fixation System is attached to the shanks of the bone screws. This submission is for the modification of the SL Rapid Clamps and the addition of a 'MRI Safe' labeling claim to the existing System when the newly modified SL Rapid Clamps are utilized. The intended use and fundamental scientific technology have not changed from the previously cleared submission.
The provided text describes a Special 510(k) Device Modification for the EBI® XFIX® Vision® Fixation System. This submission is for modifications to the SL Rapid Clamps and the addition of an 'MRI Safe' labeling claim. However, the document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about ground truth establishment.
The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K993886, K011711, K014194) based on unchanged intended use, materials, and fundamental scientific technology. The approval letter from the FDA confirms this substantial equivalence.
Therefore, I cannot provide the requested table and detailed study information as it is not present in the provided text. The document is a 510(k) summary for a device modification, which primarily focuses on demonstrating equivalence rather than presenting new clinical study data with performance metrics.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.