(266 days)
The DePuy Synthes TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally mature adults and adolescents (12-21)* for maintaining the relative position of bone grafts and/or bone graft substitutes within bone voids or surgical resections in the nonarticular regions of the humerus, femur, or tibia. The implant must be used in conjunction with traditional, rigid fixation.
*The TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally immature adolescents, only if the device is not used across open physes.
The TruMatch Graft Cage – Long Bone implant is for patients only when the treating physician deems there is appropriate time to conduct surgical planning, personalization, and manufacturing of a patient specific device. When considering the use of the TruMatch Graft Cage - Long Bone, please ensure that you request information on the amount of time needed to manufacture and ship the device from your local DePuy Synthes sales representative. There is a delay between when the device is ordered and when the device can be delivered.
DePuy Synthes TruMatch Graft Cage - Long Bone, is a 3D-printed personalized resorbable implant that optimizes support of bone graft in large, segmental defects of the humerus, femur, and tibia.
This is a medical device 510(k) summary, not a study describing the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance is not applicable to this document.
The document describes the regulatory review for a medical device called the "TruMatch Graft Cage - Long Bone" and concludes its substantial equivalence to a predicate device. The performance data provided are related to the mechanical and biological properties of the implant, not the performance of an AI/ML algorithm.
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§ 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.