Search Results

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
  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 two screw-receiving holes, surface teeth, and an area to contain grafting material. The wedges are designed in rectangular and kidney shaped footprints in a range of sizes (16x16mm to 20x22mm) and in multiple thicknesses (5 to 12mm). 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. When used without the provided screws Trigon wedges are intended for use with ancillary fixation.

The provided text describes a 510(k) premarket notification for the "Trigon HA Stand-Alone Wedge Fixation System" but does not contain information about acceptance criteria or a study proving that the device meets those criteria. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through engineering analysis comparing device characteristics (materials, intended use, processes) and the addition of steam sterilization as an alternative method.

Therefore, for aspects related to acceptance criteria, device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, the requested information is not provided in the given text.

The text does mention:

• Summary of Non-Clinical Testing: An engineering analysis was performed comparing device characteristics including materials, intended use, and processes (cleaning and sterilization methods). No FDA performance standards have been established for this device.
• Conclusion: Based on the comparison of device characteristics, the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics are assessed to be substantially equivalent.

Ask a specific question about this device