(22 days)
The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include: Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.
The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titanium screws and specialized instrumentation. The screws are available in 11 length configurations between 10mm - 30mm, with increments of 2mm. The system is provided non-sterile and is sterilized in the user facility.
This document describes the Skeletal Dynamics Headless Compression Screw System, a device for bone fixation. However, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.
Instead, the document is a 510(k) premarket notification to the FDA for a medical device. The "performance testing" mentioned refers to mechanical testing of the hardware itself (compression and ASTM F543 testing), not the performance of an AI/ML algorithm or system.
Therefore, I cannot provide the requested information for an AI/ML device. The document explicitly states:
- "Compression testing and ASTM F543 testing were performed to demonstrate conformance to the requirements."
- "The substantial equivalence of the Skeletal Dynamics Headless Compression Screw System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness."
This indicates a traditional medical device submission based on substantial equivalence for physical properties and intended use, not an AI/ML diagnostic or assistive device.
§ 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.