510(k) · Cleared
ClearedEmbedMed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Lifeprints UK, Ltd. · DZJ Driver, Wire, And Bone Drill, Manual
Cleared on Sep 30, 2022 as substantially equivalent to K201353 (Centermed, Inc., 2021) after a 234-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Sep 30, 2022
- Review
- 234 days
- Class
- Class II
- Product code
- DZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K924630 (1993). 12 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 5 generations backK033849 Simplant SystemMaterialise NV · 2004
- 4 generations backK060950 3MATICMaterialise NV · 2006
- 3 generations backK120956 VSP SystemMedical Modeling, Inc. · 2012
- 2 generations backK181241 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2018
- 1 generation backK201353 CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc. · 2021
- This deviceK220366 EmbedMed3D Lifeprints UK, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −6 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −5 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −4 | K060950 | 3MATIC | Materialise NV | 2006 | — |
| −3 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
| −2 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2018 | — |
| −1 | K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | 2021 | — |
| 0 (this device) | K220366 | EmbedMed | 3D Lifeprints UK, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
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 DZJ? 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 DZJ device
- #1 K243637 Materialise Personalized Guides and Models for…score 13.7 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemSummary page 4…Class II Product Code DZJ, LLZ 5.3. Legally Marketed Predicate Device CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K201353) 5.4. Device Description EmbedMed utilizes Commercial Off-The-Shelf (COTS) software to manipulate 3D medical images to cr… | 2021 |
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 29 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
How does its category compare?
All DZJ devicesDZJ Driver, Wire, And Bone Drill, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZJ
142in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZJ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZJ
14in 2025
MAUDE reports naming product code DZJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 142 |
| 2010 | 0 | — | 0 | 517 |
| 2011 | 0 | — | 5 | 578 |
| 2012 | 1 | — | 0 | 621 |
| 2013 | 0 | — | 1 | 809 |
| 2014 | 1 | — | 0 | 539 |
| 2015 | 2 | — | 0 | 18 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 2 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 4 | 379 | 0 | 17 |
| 2021 | 3 | 403 | 0 | 22 |
| 2022 | 3 | 179 | 0 | 23 |
| 2023 | 3 | 142 | 0 | 22 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
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 including anatomical models and surgical guides for use in maxillofacial surgeries. 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/K220366 · printed Nov 3, 2026
Cite this page
510(k) Report. “K220366: EmbedMed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K220366
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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