(87 days)
Synthes LCP Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
The Synthes LCP Proximal Humerus Plates are designed to match the anatomy of the proximal humerus. These plates can be applied to either the right or left humerus. The proximal portion of each plate has threaded holes that accept 3.5 mm or 2.7 mm screws. The distal portion of the plate has combination holes that allow the option of using 3.5 mm locking or cortex screws, or 4.0 mm cancellous screws to accomplish plate fixation. These plates will be offered as an addition to the Synthes Small Fragment LCP (formerly DCL) System.
This document is a 510(k) summary for the Synthes LCP Proximal Humerus Plate, submitted to the FDA in 2001. A 510(k) submission is for demonstrating substantial equivalence to a legally marketed predicate device, not necessarily for proving specific performance metrics against pre-defined acceptance criteria through a clinical study. Therefore, the information requested in the prompt, particularly regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set details, is not typically found in this type of regulatory document.
The document focuses on:
- Device Description: The Synthes LCP Proximal Humerus Plates are designed to match the anatomy of the proximal humerus, with threaded and combination holes for various screw types. They are an addition to the Synthes Small Fragment LCP System.
- Intended Use: Indicated for fractures, fracture-dislocations, osteotomies, and non-unions of the proximal humerus, especially in osteopenic bone.
- Materials: Available in Stainless Steel or Titanium.
- Predicate Devices: Synthes Small Fragment Dynamic Compression Locking (DCL) System and De Puy Ace Symmetry Proximal Humerus Plate.
- Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, it is not possible to answer the detailed questions about acceptance criteria, study methodologies, and performance metrics from the provided text because these elements are not part of a 510(k) substantial equivalence submission for this type of medical device at the time this document was generated.
§ 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.