(19 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™ Medial 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 tractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with three screw holes and a central cutout. There are also two k-wire guide holes for the distal metaphyseal region and a partial hole with countersink in the distal end of the cutout. 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 plate is supplied with a form along the long axis of the plate and the surgeon is expected to complete the contouring to match the individual patient anatomy. 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 and 4.0mm cancellous screw. The plate is a universal plate and can be used on the right or left tibia. The DePuy ACE TiMAX™ Medial Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).
The provided text describes a medical device, the DePuy ACE TiMAX™ Medial Pilon Plate, and its 510(k) summary for FDA clearance. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states that the DePuy ACE TiMAX™ Medial Pilon Plate is a "minor modification to the DePuy ACE TiMAX™ Pilon Plate and has been shown to have similar strength and bending properties." This suggests that a comparative analysis was performed to demonstrate "similar strength and bending properties" to an existing, cleared device, implying equivalence rather than performance against pre-defined acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory clearance through substantial equivalence, not on a detailed performance study against specific acceptance metrics.
Here's what I can extract, which is that the device claims similar properties to a predicate device:
- Device: DePuy ACE TiMAX™ Medial Pilon Plate
- Predicate Device: DePuy ACE TiMAX™ Pilon Plate
- Claim of Equivalence: The new device "has been shown to have similar strength and bending properties" to the predicate.
To answer your request thoroughly, a different type of document (e.g., a detailed engineering report, a clinical trial summary, or a specific performance testing report) would be needed, which is not present in the provided 510(k) summary.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.