(86 days)
The following fracture configurations may be applicable for treatment using TriMed Elbow and Forearm System:
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Fractures, malunions and non-unions of the radius and ulna amenable to plate and/or screw fixation where the size, shape and location of the fractured bone are appropriate for the specific implant(s) used.
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Fractures and osteotomies of the olecranon.
The TriMed® Elbow and Forearm System, comprising of bone plates, wire forms and screws, are intended to be used as an aid to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of plate and/or screw, wire form, tension band, or pin fixation. The TriMed Elbow and Forearm System plates, wire forms and screws are designed to provide additional constraint of movement of a fractured fused or osteotomized bone and are intended only as an aid to fix the fracture in place during the healing process.
The provided document does not contain information regarding acceptance criteria and a study proving a device meets these criteria. It is a 510(k) clearance letter and summary for a medical device (TriMed Elbow and Forearm System).
Here's what the document does provide:
- Device Name: TriMed Elbow and Forearm System
- Intended Use/Indications for Use: Treatment of certain types of fractures and osteotomies of the radius, ulna, and olecranon using plate and/or screw fixation, wire form, tension band, or pin fixation.
- Predicate Devices: K060041 TriMed Bone Plates and K010545 Tension Band Wire.
- Technological Comparison: The new device is stated to be substantially equivalent to predicate devices in material (316L Stainless Steel), design features, principles of operation, manufacturing, and labeling.
- Non-Clinical Tests: Static and dynamic four-point bending tests were conducted per ASTM F382-17, following FDA Guidance Document recommendations for "Orthopedic Non-Spinal Metallic Bone Screws and Washers."
- Clinical Studies: None were conducted for the subject devices.
- Predetermined Change Control Plan (PCCP): Details a future modification to combine the Olecranon Sled and Washer into a single device, with plans for biocompatibility, sterilization, and mechanical performance testing (static bend and endurance bend).
Therefore, I cannot answer the requested questions as the information is not present in the provided text. The document focuses on demonstrating substantial equivalence to existing devices based on material, design, and non-clinical mechanical testing, rather than establishing and meeting specific performance acceptance criteria through the type of study outlined in your request (e.g., studies involving human perception, AI performance, or expert ground truth).
§ 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.