(227 days)
The ARIX Wrist System(Radius) is intended for use in forearm fractures, osteotomies and arthrodesis. The ARIX Wrist System(Ulna) is intended for fractures and osteotomies, in particular for the ulna.
The ARIX Wrist System is consists of the Radius & Ulna. It is rigid fixation plates and screws which were recommended combination as follow;
Type / Configuration: Radius, Ulna
Plate: 25-DVRA Series, 25-DLUL Series
Screw: Self-tapping Cortical Screw (25-HF Series), Self-tapping Locking Screw (161.0325 Series for Radius, 25L-HF Series for Ulna)
Material: ASTM F 67 Pure Titanium (Plate), ASTM F 136 Titanium Alloy (Ti-6Al-4V) (Screws)
The ARIX Wrist System is made of Pure Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which h are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The self-tapping cortical screws & self-tapping locking screws diameter is 2.5mm and lengths is from 8mm to 38mm. It also includes various manual surgical instruments, as drill guides, drill bits, driver shafts, depth gauge, bender and handbody etc,. The ARIX Wrist System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery.
This document is a 510(k) premarket notification for the "ARIX Wrist System" and does not contain information about an AI/ML powered device. Therefore, it is not possible to extract the requested information regarding acceptance criteria, study details, and AI/ML specific aspects from this document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices for a medical implant (bone plates and screws) through material composition, design features, and non-clinical bench testing.
§ 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.