510(k) · Cleared

Cleared

Stratasys FDM Medmodeler System

K971290510(k) TraditionalCleared Jun 20, 199774-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

Paladin Medical, Inc. · LLZ System, Image Processing, Radiological

Cleared on Jun 20, 1997 as substantially equivalent to K924630 (Surgicad Corp., 1993) after a 74-day review. Its family tree reaches back 1 generation to 1993.

Decided: Jun 20, 1997
Review: 74 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K924630 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
This deviceK971290 Stratasys FDM Medmodeler SystemPaladin Medical, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924630	Surgicad (TM) View (TM)	Surgicad Corp.	1993	—
0 (this device)	K971290	Stratasys FDM Medmodeler System	Paladin Medical, Inc.	1997	—

FIG. 1 — Lineage of K971290, 1993–1997Source: 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
*	K924630	Surgicad (TM) View (TM) Summary page 1 …TANTIALLY EQUIVALENT TO: The Stratasys FDM MedModeler System is substantially equivalent to the SurgiCAD image processing accessory accepted under premarket notification K924630. DESCRIPTION of the DEVICE: The Stratasys FDM MedModeler produces anatomical models for use in a variety of medical applications…	Surgicad Corp.	1993	—

Also cleared against K924630: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
1 other device also cites its predicate K924630.

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.

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?

The Stratasys FDM MedModeler is indicated as an image processing accessory, used to create three dimensional models from 3D surface representation data or 2D contour data as a diagnostic tool, as a pre-operative planning tool, and to enhance communication with patients, other professionals or students.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971290 · printed Nov 5, 2026

Cite this page

510(k) Report. “K971290: Stratasys FDM Medmodeler System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971290

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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