510(k) · Cleared
ClearedCenterMed Patient Matched Assisted Surgical Planning (ASP) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centermed, Inc. · DZJ Driver, Wire, And Bone Drill, Manual
Cleared on Jun 28, 2021 as substantially equivalent to K181241 (KLS-Martin L.P., 2018) after a 403-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Jun 28, 2021
- Review
- 403 days
- Class
- Class II
- Product code
- DZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924630 (1993). 11 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK060950 3MATICMaterialise NV · 2006
- 2 generations backK120956 VSP SystemMedical Modeling, Inc. · 2012
- 1 generation backK181241 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2018
- This deviceK201353 CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK220366 EmbedMed3D Lifeprints UK, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220366EmbedMed3D Lifeprints UK, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K060950 | 3MATIC | Materialise NV | 2006 | — |
| −2 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
| −1 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2018 | — |
| 0 (this device) | K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning SystemSummary page 4…Class II Product Code: DZJ, LLZ Predicate Device: KLS Martin Individual Patient Solutions (IPS) Planning System (K181241) Device Description: CenterMed Patient Matched Assisted Surgical Planning (ASP) System is a c… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220366 | EmbedMed | 2022 | 0 |
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 28 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K220366 (3D Lifeprints UK, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K181241.
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. 2021, 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?
CenterMed Patient Matched Assisted Surgical Planning (ASP) System 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 ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs…
Read the full statement (114 words)
CenterMed Patient Matched Assisted Surgical Planning (ASP) System 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 ASP system and the result is an output data file. This file may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical guides, surgical splints and surgical planning case reports for use in maxillofacial surgery. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201353: CenterMed Patient Matched Assisted Surgical Planning (ASP) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201353
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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