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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 Fusion
• · First Metatarsal-Cuneiform Lengthening Arthrodesis
• · Calcaneocuboid Arthrodesis
• · Z-Calcaneal Lengthening Osteotomies
• · MTP Lengthening Arthrodesis

The Trigon HA Stand-Alone Wedge Fixation System is intended for use with ancillary fixation and 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 two screw-receiving holes, surface teeth, 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, and MTP 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 FDA 510(k) clearance letter and summary describe a medical device, the Trigon HA Stand-Alone Wedge Fixation System, and its substantial equivalence to previously cleared predicate devices. However, it does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria.

Specifically, the document states:

• "No FDA performance standards have been established for the Trigon HA Stand-Alone Wedge Fixation System."
• The "SUMMARY OF NON-CLINICAL TESTING" section indicates that "Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)" was performed.
• The conclusion is based on "comparison of device characteristics," "similar indications for use, technological characteristics, and performance characteristics" to predicate devices.

Therefore, I cannot provide the requested information because it is not present in the provided text. The submission relies on demonstrating substantial equivalence to predicate devices through engineering analysis and comparison, rather than an independent study with defined acceptance criteria for the new device's performance.

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