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This document provides a summary of safety and effectiveness information for the Comprehensive® Proximal Humeral Plating System, which is regulated by the FDA as a medical device intended for bone

How to fill out 510k summary comprehensive proximal

How to fill out 510(k) Summary Comprehensive® Proximal Humeral Plating System

1. Gather all necessary product information including device specifications and intended use.
2. Complete the pre-market notification form (FDA Form 3514).
3. Prepare a detailed description of the Comprehensive® Proximal Humeral Plating System, including design, materials, and operating principles.
4. Conduct and document performance testing, including mechanical and safety evaluations.
5. Provide summary data comparing the device with predicate devices to demonstrate substantial equivalence.
6. Compile labeling information, including instructions for use and contraindications.
7. Conduct risk analysis and document any potential hazards associated with device use.
8. Prepare a summary of any clinical data if applicable, including outcomes that support device safety and effectiveness.
9. Review and ensure compliance with FDA regulations governing medical devices.
10. Submit the completed 510(k) application to the FDA and monitor for any additional information requests.

Who needs 510(k) Summary Comprehensive® Proximal Humeral Plating System?

1. Orthopedic surgeons who perform proximal humeral fracture repairs.
2. Clinics and hospitals specializing in orthopedic surgery.
3. Patients requiring surgical intervention for proximal humeral fractures.
4. Medical institutions aiming to expand their orthopedic device offerings.

People Also Ask about

What is humerus ap?

The humerus is positioned AP, evidenced by the medial and lateral epicondyles seen in profile and the greater tubercle being seen on the lateral aspect of the humerus. The shaft is abducted away from the patient's body, minimizing superimposition.

What are the acceptable criteria for a humerus fracture?

Fracture alignment is maintained by the soft tissue envelope of the upper arm which has been described as the inner splint. Indications for nonoperative treatment include acceptable alignment less than 20 degrees anterior angulation, less than 30 degrees varus, valgus angulation, and less than 3 centimeters shortening.

When evaluating an image of an AP humerus, what criteria indicates proper positioning?

When taking an AP projection, it's essential to position the humerus so that the bony prominences, called epicondyles, located at the distal end of the humerus, appear as a single continuous line. This alignment shows that the arm is not rotated, which is critical for obtaining a clear and diagnostic image.

What is AP humerus evaluation criteria?

Evaluation criteria for AP projection of humerus The greater tubercle is seen in profile laterally. The humeral head is partially seen in profile medially, with minimal superimposition of the glenoid cavity. The distal humerus should show both lateral and medial epicondyles visualized in profile.

What are the criteria for AP elbow?

For AP elbow joint radiographs, the following conditions should be met [4]: (1) the distal humerus, proximal ulna and radius, and their joint spaces are centered in the image; (2) the elbow joint surfaces are tangentially aligned, sharply defined, with the coronoid fossa slightly ulnar to the center of the medial and

What is the proximal humerus plate technique?

The proximal portion of the plate is placed on the lateral surface and the distal portion is placed on the anterior surface of the humerus. This requires the plate to be twisted to form a helix, with sufficient twist to allow the plate to pass anteriorly to the deltoid insertion.

For pdfFiller’s FAQs

What is 510(k) Summary Comprehensive® Proximal Humeral Plating System?

The 510(k) Summary Comprehensive® Proximal Humeral Plating System is a medical device intended for the fixation of fractures, osteotomies, and reconstructions of the proximal humerus. It is used to stabilize the bone and promote healing.

Who is required to file 510(k) Summary Comprehensive® Proximal Humeral Plating System?

Manufacturers of the Comprehensive® Proximal Humeral Plating System are required to file a 510(k) submission to the FDA to demonstrate that their device is safe and effective for use in patients.

How to fill out 510(k) Summary Comprehensive® Proximal Humeral Plating System?

To fill out the 510(k) summary, manufacturers need to follow the FDA guidelines which include providing information about the device, its intended use, a comparison with a predicate device, and supporting data for safety and effectiveness.

What is the purpose of 510(k) Summary Comprehensive® Proximal Humeral Plating System?

The purpose of the 510(k) Summary is to provide the FDA with sufficient information to determine whether the Comprehensive® Proximal Humeral Plating System is substantially equivalent to an already legally marketed device.

What information must be reported on 510(k) Summary Comprehensive® Proximal Humeral Plating System?

The 510(k) Summary must report device descriptions, intended use, indications for use, technological characteristics, labeling, and any clinical data supporting safety and effectiveness.