(27 days)
The Skeletal Dynamics Distal Elbow Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius and ulna, particularly in osteopenic bone.
The Skeletal Dynamics Distal Elbow Plating System is comprised of:
- Titanium alloy plates and screws in various configurations
- Cobalt chrome polyaxial screws
- Stainless steel K-wires (for provisional fixation not for implantation)
- System specific instrumentation
The current Skeletal Dynamics Distal Elbow Plating System (K140892) includes the radial head and proximal ulna plates. Plates in double hockey stick, Y and coronoid shape configurations with the same node and inter-node features as the radial head plate are being added for use in the proximal radius and ulna in this submission. All plates are made of medical grade titanium alloy. The radial head, proximal ulna and coronoid plates are offered in left and right applications, the proximal ulna plate is provided in various lengths, and the double hockey stick and Y plates are in single size and have bilateral application. Additional screws length as well as new threaded pegs, washers, polyaxial locking screws, and instruments have been added in the subject system in this submission. The system is provided non-sterile and is sterilized in the user facility.
This document is a 510(k) premarket notification for a medical device called the "Skeletal Dynamics Distal Elbow Plating System." It is not about an AI/ML medical device. Therefore, the information requested about acceptance criteria and study design for an AI/ML device, such as sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment, cannot be found in this document.
The document describes a traditional orthopaedic medical device (bone plates and screws) and demonstrates its substantial equivalence to previously cleared predicate devices through engineering analysis and preclinical mechanical testing, adhering to ASTM standards. There is no mention of algorithms, artificial intelligence, or machine learning.
§ 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.