(59 days)
DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and Proximal Femur Hook Plates are indicated for the treatment of periprosthetic fractures in the presence of intramedullary implants in the proximal end segment and the proximal and middle 1/3 of the diaphyseal segment of the femur, and non-unions of such fractures, in adult patients, particularly in osteoporotic and osteopenic bone.
DePuy Synthes 3.5 mm VA Locking Attachment Plate is indicated to augment the stabilization of fractures, including periprosthetic fractures (Vancouver Type B when used with either the 3.5 mm VA-LCP PPFx Proximal Femur Plate or Proximal Femur Hook Plate; Vancouver Type B and C when used with other DePuy Synthes LCP plates and VA-LCP plates) and fractures in the presence of intramedullary implants, in the femur, tibia, and humerus.
DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates (when used with either 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate or the Proximal Femur Hook Plate) can be used to extend the length of a plate construct to the lateral condyles.
DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring Attachment Plates (when used with 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate) are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.
DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook Plates are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.
The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System of Stainless Steel Plates for periprosthetic fractures. It consists of plates that offer screw to plate non-locking constructs, locking constructs or a combination of both. The plates accept commercially available DePuy Synthes Stainless Steel 3.5 mm cortex screws, 3.5 mm (variable angle) locking screws, 4.5 mm cortex screws and 5.0 mm (variable angle) locking screws, as well as the Synthes Orthopaedic Cable system.
The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System offers:
• 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates
• 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Hook Plates
• 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plate
• 3.5 mm VA Locking PPFx Greater Trochanter Hook Plate
• 3.5 mm VA Locking PPFx Greater Trochanter Ring Attachment Plate
• 3.5 mm VA Locking Attachment Plate
This document is a 510(k) Premarket Notification from the FDA for a medical device. It describes the device, its intended use, and its comparison to predicate devices, along with non-clinical performance data. However, it does NOT describe an AI/ML powered device, nor does it contain any information about a study proving device meets acceptance criteria related to AI/ML performance, such as human reader improvement with AI assistance, standalone algorithm performance, or the establishment of ground truth by multiple experts.
Therefore, I cannot provide the requested information. The document focuses on the substantial equivalence of a physical orthopedic implant system to existing predicate devices, based on mechanical, MRI compatibility, sterilization, shelf-life, and biological safety testing. It does not mention any AI or machine learning components.
§ 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.