(108 days)
The AxSOS 3 Ankle Fusion System is indicated for arthrodesis of the includes tibio-talo-calcaneal, tibiotalar, and tibio-calcaneal arthrodesis, in possible conjunction with osteotomies of the distal tibia, talus, and calcaneus.
AxSOS 3 Ti is intended for long bone fracture fixation.
Indications include:
- · Diaphyseal, metaphyseal, extra- and intra-articular fractures
- · Non-unions and malunions
- · Normal and osteopenic bone
- · Osteotomies
- · Periprosthetic fractures of the femur and proximal tibia
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
- · Periprosthetic fractures
- · Diaphyseal and metaphyseal areas of long bones in pediatric patients
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
Screws can also be used for arthrodesis.
AxSOS 3 AF (Ankle Fusion) is an internal fixation system composed of sterile and non-sterile plates, and associated instruments. These plates are available in a variety of anatomical orientations and made of titanium alloy, with Type II anodization, and used with compatible screws.
AxSOS 3 Ti is an internal fixation system composed of sterile and non-sterile plates, screws, and complementary, implantable devices, along with associated instruments. The plates are available in a variety of anatomical orientations and lengths. Implants of this system are available in titanium alloy, with Type II anodization.
I am sorry, but the provided text does not contain information about acceptance criteria or specific studies proving a device meets these criteria. The document is a 510(k) premarket notification for the AxSOS 3 AF System and AxSOS 3 Ti System, which details the device's indications for use, technological characteristics, and a summary of non-clinical performance data (mechanical testing and MR compatibility).
It explicitly states: "Clinical testing was not a requirement for this submission."
Therefore, I cannot extract the information required for your request, as clinical acceptance criteria, detailed performance results demonstrating meeting those criteria, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details are not present in this document.
§ 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.