(56 days)
- Pilon fractures - distal tibial intra-articular fractures
- High medial malleolar fractures
- Low Boot top type rotational distal extra-articular shaft fractures
The DePuy ACE TiMAX™ Pilon Plate is a fracture fixation plate intended for use in pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft fractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with four screw holes and two k-wire guide holes for the distal metaphyseal region, and finally, an arm which wraps anteriorly to address the anterior crush fracture and facilitate articular surface reconstruction. The plate thickness is 1.6 mm in the shaft region and is decreased to 1 mm in the distal region to facilitate contouring and maintaining anatomic reduction of the fracture. The shaft portion is thicker for strength. The plate is supplied pre-formed to a contour, which closely matches the distal tibia anatomy. The general contour includes a medial bend from the distal metaphyseal region combined with an internal rotation. The most distal profile includes the anterior arm with a large bend from the medial to the anterior surface with the bend apex located adjacent to the anterior strut. The open architecture of the distal region allows easy contouring by the surgeon to accommodate the anatomical topography of the distal tibia and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw, 4.0mm cancellous screw, and the periarticular screw. The plate will be offered in a right and left model with various lengths of the shaft region. The DePuy ACE TiMAX™ Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).
This looks like a submission for a medical device (bone fixation plate) and not AI/ML software. The provided text describes the device, its intended use, and its substantial equivalence to a predicate device based on mechanical properties. It does not contain information about acceptance criteria, performance metrics, ground truth, or study details typically associated with AI/ML device evaluations. Therefore, I cannot extract the requested information from the provided text.
§ 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.