510(k) · Cleared
ClearedMaterialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · PPT Cranial Surgical Planning And Instrument Guides
Cleared on Jan 7, 2026 as substantially equivalent to K243637 (Materialise NV, 2025) after a 100-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Jan 7, 2026
- Review
- 100 days
- Class
- Class II
- Product code
- PPT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K924630 (1993). 13 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 8 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 7 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 6 generations backK033849 Simplant SystemMaterialise NV · 2004
- 5 generations backK060950 3MATICMaterialise NV · 2006
- 4 generations backK120956 VSP SystemMedical Modeling, Inc. · 2012
- 3 generations backK181241 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2018
- 2 generations backK182789 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2019
- 1 generation backK243637 Materialise Personalized Guides and Models for Craniomaxillofacial…Materialise NV · 2025
- This deviceK253308 Materialise Personalized Guides and Models for Craniomaxillofacial…Materialise NV · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −7 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −6 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −5 | K060950 | 3MATIC | Materialise NV | 2006 | — |
| −4 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
| −3 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2018 | — |
| −2 | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2019 | — |
| −1 | K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | 2025 | — |
| 0 (this device) | 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 |
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 PPT? 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 PPT device
- #1 K201052 KLS Martin Individual Patient Solutions (IPS)…score 1.7 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgerySummary page 6…Materialise Personalized Guides and Models for Craniomaxillofacial Surgery 510(k) number K243637 Decision date 21/02/2025 Product code DZJ, LLZ Manufacturer… | 2025 |
| † | K111558 | Surgicase Guide | 2012 |
| † | K201052 | KLS Martin Individual Patient Solutions (IPS) Planning System | 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 33 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 13 ancestors has a recall of any class.
How does its category compare?
All PPT devicesPPT Cranial Surgical Planning And Instrument Guides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PPT
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PPT
Too few PPT 510(k)s in any year since 2007 to give a median.
Recalls per year · PPT
No recall names PPT since 2007.
Adverse event reports per year · PPT
No MAUDE report names PPT since 2007.
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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
CMF Titanium Guides CMF Titanium Guides are intended to guide the marking of bone and/or guide surgical instruments in craniofacial 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…
Read the full statement (150 words)
CMF Titanium Guides
CMF Titanium Guides are intended to guide the marking of bone and/or guide surgical instruments in craniofacial 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 craniomaxillofacial surgery.
CMF Plastic Models
CMF Plastic Models 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 craniofacial 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 craniomaxillofacial surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253308: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253308
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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