(84 days)
Magly 6.5mm Cannulated Screws are generally intended for fracture fixation of large bones and large bone fragments.
Indication(s) for Use:
- Femoral neck fractures
- Metaphyseal fractures of the distal femur and tibia
- Fractures of the tibial plateau
- Fractures of the humerus, olecranon process, scapuls, and os calcis
- Fractures of the sacrum, acetabulum, and pelvic ring
- Fixation of the ileo-sacral joint
- Fusions of the foot and ankle
Magly 6.5mm Cannulated Screws are of a single thread profile with a nominal major diameter of 6.5mm and can be used in conjunction with a guide wire for precise placement.
At the distal tip the screws will incorporate 20mm of thread and will embody five cutting flutes that are used for reaming and tapping the thread profile. Located at the thread runout to the shank, we placed two reverse cutting flutes, located 180° to each other, to assist in the removal of the screw.
The screws will be available in 5mm incremental lengths, from 30mm-150mm.
Magly 6.5mm Cannulated Screws will be manufactured from titanium alloy
This is a 510(k) premarket notification for a medical device (Magly 6.5mm Cannulated Screws), not a study report for a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML diagnostic tools, is not present in this document.
The document describes the device, its intended use, and states that it is "substantially equivalent" to a predicate device (DePuy/ACE 6.5mm Titanium Cannulated Cancellous Screws). This substantial equivalence is based on similarities in design, function, materials used, and indications for use, rather than a performance study with specific metrics and acceptance criteria as would be expected for an AI/ML diagnostic device.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other details related to a diagnostic performance study from the provided text.
§ 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.