(237 days)
The Integra Proximal Humeral Fracture Plate System is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications include:
- Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures . involving osteopenic bone
- Pseudoarthroses in the proximal humerus .
- Osteotomies in the proximal humerus .
The Integra Proximal Humeral Fracture Plate System is composed of left and right humeral reconstruction plate implants in two options, GT Plate and LP Plate. The GT plate is designed to cover the greater tuberosity and is available in four-hole , seven-hole, and ten-hole lengths or sizes. The LP plate is designed to sit lower on the greater tuberosity and is available in three-hole, six-hole, and nine-hole lengths or sizes. The system features 3.5mm locking, non-locking and lag screws, in addition to, 2.7mm locking screws. The Integra Proximal Humeral Fracture Plate System is a single component made from stainless steel (SS 316L). The non-locking, locking and lag screws are made from stainless steel (SS 316L).
This document is a 510(k) premarket notification for a medical device (Integra Proximal Humeral Fracture Plate System), not a study evaluating software or an AI device. Therefore, the requested information (acceptance criteria, study details, human reader performance, ground truth, etc.) is not applicable and cannot be extracted from the provided text.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use for regulatory approval. It explicitly states, "Clinical performance data were not necessary to support substantial equivalence."
§ 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.