510(k) · Cleared

Cleared

Mimics inPrint

K173619510(k) TraditionalCleared Mar 21, 2018119-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Materialise NV · LLZ System, Image Processing, Radiological

Cleared on Mar 21, 2018 as substantially equivalent to K073468 (Materialise NV, 2008) after a 119-day review. Its family tree reaches back 4 generations to 1993. 13 later devices descend from it.

Decided: Mar 21, 2018
Review: 119 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K924630 (1993). 5 ancestors in all, the oldest K924810 (1993). 13 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 4 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
3 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
2 generations backK033849 Simplant SystemMaterialise NV · 2004
1 generation backK073468 MimicsMaterialise NV · 2008
This deviceK173619 Mimics inPrintMaterialise NV · 2018
Descendant · cites it directly · 4 of its ownK221511 Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 2022
Descendant · 2 generations on · 2 of its ownK222745 Axial3D InsightAxial Medical Printing Limited · 2023
Descendant · cites it directly · 2 of its ownK191026 Medip ProMedical IP Co., Ltd. · 2019
Descendant · cites it directly · 2 of its ownK190874 Materialise Mimics EnlightMaterialise NV · 2019
Descendant · 3 generations on · 1 of its ownK232841 Axial3D InsightAxial Medical Printing Limited · 2023

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2019high 4 (2023) · low 0 (2020)2026

Most influential descendants

Showing 5 of 13 · See all

K221511Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited · 2022 · cites it directly4descendants
K222745Axial3D InsightAxial Medical Printing Limited · 2023 · 2 generations on2descendants
K191026Medip ProMedical IP Co., Ltd. · 2019 · cites it directly2descendants
K190874Materialise Mimics EnlightMaterialise NV · 2019 · cites it directly2descendants
K232841Axial3D InsightAxial Medical Printing Limited · 2023 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K924630	Surgicad (TM) View (TM)	Surgicad Corp.	1993	—
−3	K970617	CT-Modeller System	Materialise NV	1997	—
−2	K033849	Simplant System	Materialise NV	2004	—
−1	K073468	Mimics	Materialise NV	2008	—
0 (this device)	K173619	Mimics inPrint	Materialise NV	2018	—
+1	K221511	Axial3D Cloud Segmentation Service	Axial Medical Printing Limited	2022	—
+2	K222745	Axial3D Insight	Axial Medical Printing Limited	2023	—
+1	K191026	Medip Pro	Medical IP Co., Ltd.	2019	—
+1	K190874	Materialise Mimics Enlight	Materialise NV	2019	—
+3	K232841	Axial3D Insight	Axial Medical Printing Limited	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	2	0
2022	2	0
2023	4	0
2024	2	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K173619, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K073468	Mimics Summary page 4 …Trade or proprietary or model name Mimics Zimmer Patient Specific Instrument 510(k) K073468 Systemnumber 2.5 Decision date April 2nd, 2008 Materialise N.V…	Materialise NV	2008	—
†	K161841	D2P	3D Systems, Inc.	2017	—

Also cleared against K073468: 8 other devices →

What descends from it? (13)

See all 13

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K221511	Axial3D Cloud Segmentation Service	Axial Medical Printing Limited	2022	4
K191026	Medip Pro	Medical IP Co., Ltd.	2019	2
K190874	Materialise Mimics Enlight	Materialise NV	2019	2
K220205	3D Anatomic Models	Ricoh USA, Inc.	2022	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K221511 (Axial Medical Printing Limited, 2022) has gone furthest, with 4 descendants of its own.
8 other devices also cite its predicate K073468.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

Mimics inPrint is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre-operative software for treatment planning. For this purpose, the Mimics inPrint output file 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 orthopedic, maxillofacial and cardiovascular applications. Mimics inPrint should be used in conjunction with other diagnostic tools and expert clinical judgement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K173619 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173619: Mimics inPrint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173619

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026