510(k) · Cleared

Cleared

EmbedMed

K221943510(k) TraditionalCleared Feb 1, 2023211-day reviewClass II21 CFR 888.3030

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

3D Lifeprints UK, Ltd. · PBF Orthopaedic Surgical Planning And Instrument Guides

Cleared on Feb 1, 2023 as substantially equivalent to K212237 (3D-Side S.A., 2021) after a 211-day review. Its family tree reaches back 2 generations to 2019.

Decided: Feb 1, 2023
Review: 211 days
Class: Class II
Product code: PBF
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K190044 (2019). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK190044 VSP Orthopedics System3D Systems, Inc. · 2019
1 generation backK212237 3D-Cut3D-Side S.A. · 2021
This deviceK221943 EmbedMed3D Lifeprints UK, Ltd. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K190044	VSP Orthopedics System	3D Systems, Inc.	2019	—
−1	K212237	3D-Cut	3D-Side S.A.	2021	—
0 (this device)	K221943	EmbedMed	3D Lifeprints UK, Ltd.	2023	—

FIG. 1 — Lineage of K221943, 2019–2023Source: 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 PBF? 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 PBF device

#1 K241811 MedCAD® AccuStride™ Systemscore 17.1 · 8 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
*	K212237	3D-Cut Summary page 4 …Number 21 CFR § 888.3030 Regulatory Class: Class II Product Code PBF, LLZ Legally Marketed Predicate Device Primary: 3D-Cut (K212237) Reference: Fine Osteotomy (K193614) Page 1 of 8…	3D-Side S.A.	2021	—
†	K193614	FINE Osteotomy around the knee	Bodycad Laboratories, Inc.	2020	—

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?

The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All PBF devices

PBF Orthopaedic Surgical Planning And Instrument Guides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · PBF

8in 2025

2007high 8 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PBF

227in 2025

2007high 435 (2022) · low 62 (2024)2026

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

Recalls per year · PBF

No recall names PBF since 2007.

Adverse event reports per year · PBF

62in 2025

2007high 62 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	2
2013	0	—	0
2014	1	—	1
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	0	—	2
2019	1	—	1
2020	1	—	2
2021	2	—	12
2022	3	435	53
2023	5	314	45
2024	3	62	34
2025	8	227	62
2026	1	—	—

What is it indicated for?

EmbedMed is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the system, and the result is an output data file. This file may then be provided as digital models or used an input to an additive manufacturing portion of the system. The additive manufacturing portion of the system produces physical outputs…

Read the full statement (124 words)

EmbedMed is intended for use as a software system and image segmentation system for the transfer of imaging

information from a medical scanner such as a CT based system. The input data file is processed by the system, and the

result is an output data file. This file may then be provided as digital models or used an input to an additive manufacturing

portion of the system. The additive manufacturing portion of the system produces physical outputs including anatomical

models and surgical guides for use in the marking of bone and/or in guiding surgical instruments in non-acute, non-joint

replacing osteotomies, including the resection of bone tumors, for the appendicular skeleton. EmbedMed is also intended

as a pre-operative software tool for simulating/evaluating surgical treatment options.

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/K221943 · printed Nov 6, 2026

Cite this page

510(k) Report. “K221943: EmbedMed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221943

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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