(32 days)
The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.
TriMed Bone Plates is a system of plates, screws and surgical accessories used in the fixation of small and long bone fractures. The plates and screws are all made of stainless steel.
The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications for the TriMed Bone Plates.
The documents are a 510(k) summary and the FDA's clearance letter for the device. These documents primarily focus on:
- Device Description: The TriMed Bone Plates are a system of plates, screws, and surgical accessories made of stainless steel for small and long bone fracture fixation.
- Intended Use: Fixation of fractures to the Tibia, Fibula, Ulna, Radius, and Humerus.
- Substantial Equivalence: The product compares itself to existing predicate devices (K013655 Acumed Congruent Bone Plate System and K051735 Smith & Nephew PERI-LOC). The FDA clearance is based on this claim of substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, or study details based on the provided text. The 510(k) clearance process for devices like bone plates often relies on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria in the same way a novel diagnostic or AI-driven device might.
§ 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.