SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

The SixFixTM Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is a web-based orthopedic software tool used with a circular external fixator to correct bone deformities and fractures. It uses radiographs and surgeon inputs to develop treatment plans for conditions including joint contractures, fractures, limb lengthening, and bone deformities. Use of the software is optional for surgeons employing the SixFixTM Hexapod fixator.

The subject device is a web-based version of the predicate software, whereas the predicate was installed locally on off-the-shelf computer hardware. The new version runs on updated operating systems with support for current web browsers, includes minor changes in image formats, and adds an optional additional user role. The indications for use, user inputs, device outputs, and principle of operations remain identical to the predicate.

Not stated in this summary.

The device is substantially equivalent because the indications for use, clinical functionality, device outputs, and operational principles are identical to the predicate device. The change from locally-installed to web-based architecture does not raise different safety or effectiveness questions, as similar risks were identified and mitigated in both versions using the same recognized standards. Functional testing with 43 test cases demonstrated equivalent or superior performance compared to the predicate device.