510(k) · Cleared
ClearedMaterialise Personalized Guides and Models for Craniomaxillofacial Surgery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · DZJ Driver, Wire, And Bone Drill, Manual
Cleared on Feb 21, 2025 as substantially equivalent to K182789 (KLS-Martin L.P., 2019) after an 88-day review. Its family tree reaches back 7 generations to 1993. 1 later device descends from it.
- Decided
- Feb 21, 2025
- Review
- 88 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). 1 later device descends from it, 1 citing it directly.
- 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 backK182789 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2019
- This deviceK243637 Materialise Personalized Guides and Models for Craniomaxillofacial…Materialise NV · 2025
- Descendant · cites it directly · 0 of its ownK253308 Materialise Personalized Guides and Models for Craniomaxillofacial…Materialise NV · 2026
Most influential descendants
Showing 1 of 1 · See all- K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…Materialise NV · 2026 · cites it directly0descendants
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 | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2019 | — |
| 0 (this device) | K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | 2025 | — |
| +1 | K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF… | Materialise NV | 2026 | — |
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 |
|---|---|---|
| 2026 | 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 K261826 VSP System (Titanium Palatal Splint)score 13.5 · 8 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 |
|---|---|---|---|
| * | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning SystemSummary page 6…me KLS Martin Individual Patient Solutions (IPS) Planning System 510(k) number K182789 Decision date 03/11/2019 Product code DZJ (21 CFR 872.4120) M… | 2019 |
| † | K173039 | TruMatch CMF Titanium 3D Printed Implant | 2018 |
| † | K170272 | TruMatch CMF Titanium 3D Printed Implant System | 2017 |
| † | K111558 | Surgicase Guide | 2012 |
| † | K103136 | Surgicase CMF, Surgicase Connect, Surgicase Guide | 2011 |
| † | K210731 | KLS Martin Individual Patient Solutions | 2022 |
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 |
|---|---|---|---|
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium… | 2026 | 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 32 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K253308 (Materialise NV, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K182789.
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. 2025, 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?
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery Materialise Personalized Guides for Craniomaxillofacial Surgery Materialise Personalized Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and/or guide surgical instruments in facial surgery. CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting)…
Read the full statement (172 words)
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
Materialise Personalized Guides for Craniomaxillofacial Surgery
Materialise Personalized Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and/or guide surgical instruments in facial surgery.
CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications.
CMF Titanium Guides are intended for children, adolescents and adults.
CMF Titanium Guides are intended for single use only.
CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery.
Materialise Personalized Models for Craniomaxillofacial Surgery
Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures.
CMF Plastic Models are intended for infants, children, adolescents and adults.
CMF Plastic Models are intended for single use only.
CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243637: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243637
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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