(30 days)
The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- · Cotton (opening wedge) Osteotomies of the Medial Cuneiform
- · Evans Lengthening Osteotomies
- · Subtalar Arthrodesis
- · First Metatarsal-Cuneiform Lengthening Arthrodesis
- · Calcaneocuboid Arthrodesis
- · Calcaneal Z Lengthening Osteotomies
- · MTP Lengthening Arthrodesis
- · Lesser Metatarsal-Cuneiform Lengthening Arthrodesis
- · Navicular-Cuneiform Arthrodesis
- · Talonavicular Arthrodesis
The Trigon HA wedges are intended for use with ancillary fixation.
The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate an inserter-receiving hole and/or two screw-receiving holes and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular, oval, and teardrop shaped footprints in a range of sizes and in multiple thicknesses. The associated 2.5mm diameter titanium screws are designed in lengths of 10 to 30mm.
When used with the provided screw fixation the Trigon wedges may be used with or without ancillary plating. Lapidus, Calcaneocuboid, MTP, Lesser Metatarsal, and Midfoot Wedges require additional fixation not provided in the Trigon System. When used without the provided screws, Trigon wedges are intended for use with ancillary fixation.
This document is a 510(k) premarket notification for the Trigon PEEK HA Wedges, which are part of the Trigon HA Stand-Alone Wedge Fixation System. This is a notification for a medical device and not a study involving AI/ML software. Therefore, it does not contain the requested information about acceptance criteria, device performance from a clinical study, sample sizes, expert ground truth adjudication, MRMC studies, standalone performance, or training set details, as these are typically associated with AI/ML software evaluations.
The document focuses on demonstrating substantial equivalence to predicate devices based on engineering analysis, materials, intended use, and processes, rather than a clinical performance study with defined acceptance criteria and statistical outcomes against a ground truth.
Specifically, the document states:
- "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System."
- "The following was performed to demonstrate safety per methods of the previous submission: Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)"
- "The results of this comparison indicate that the Trigon HA Stand-Alone Wedge Fixation System is substantially equivalent to the predicate devices."
Therefore, I cannot provide the requested information from the provided text.
§ 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.