# K132636: Dyonics Plan Hip Impingement Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 17, 2013 after 56 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924630 (1993). 5 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073468: Mimics, Materialise NV (2008) Summary page 1.

## Most influential descendants
- K173390: hipEOS (2018), 8 descendants of its own
- K212040: RI.Hip Modeler (2022), 3 descendants of its own
- K192656: Optimized Positioning System (OPS) Insight (2020), 3 descendants of its own
- K162559: Move Forward 3D Motion Simulation Service (2017), 2 descendants of its own
- K242272: CORIOGRAPH Pre-Op Planning and Modeling Services (2024), 1 descendant of its own

## Indications for use
The DYONICS PLAN Hip Impingement Planning System software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review, respectively.

Source page: https://510kreport.com/device/K132636
Methodology: https://510kreport.com/methodology