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# AMDT Holdings 510(k) for Deformity Analyzer
- URL: https://www.fdaweb.com/amdt-holdings-510-k-for-deformity-analyzer/
- Published: 2018-09-06T12:00:00.000Z
- Updated: 2026-09-15T00:30:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142287

FDA has cleared an AMDT Holdings 510(k) for its SixFix deformity analysis and correction software and instrumentation. The device, indicated for use with the Smith & Nephew Taylor Spatial Frame, reduces the time and effort involved in manual input of measurements and their values as required by currently available alternatives, and generates a prescription defining the incremental strut adjustments that will ultimately correct the deformity, the company says. “With the SixFix system, the surgeon attaches the system’s six radiopaque fiducial markers to the rings of a spatial frame external fixator, and inputs readily available spatial frame characteristics, such as ring diameter, strut length and axial rotation, into the SixFix software,” it says. “This information is used to graphically map the deformity with line segments that define the axes of the bone fragments. The software utilizes sophisticated algorithms to correct imperfections present in all radiographs, such as variable magnification and perspective distortion, in the process of creating a precise 3-D replica of the frame and the deformity.”