# K183105: Mimics Medical

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Mar 27, 2019 after 139 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.
34 later devices descend from it; 17 cite it directly.
0 of 40 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 4.

## Most influential descendants
- K203290: Bonelogic (2021), 5 descendants of its own
- K223757: Bonelogic (2023), 4 descendants of its own
- K234009: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2024), 3 descendants of its own
- K212420: Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio (2021), 3 descendants of its own
- K240642: SMART Bun-Yo-Matic CT (2024), 2 descendants of its own

## Indications for use
Mimics Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Mimics Medical is also intended for measuring and treatment planning. The Mimics Medical output can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of orthopaedic, maxillofacial and cardiovascular applications. Mimics Medical should be used in conjunction with expert clinical judgement.

Source page: https://510kreport.com/device/K183105
Methodology: https://510kreport.com/methodology