510(k) · Cleared
ClearedMedCAD AccuPlan System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcad · DZJ Driver, Wire, And Bone Drill, Manual
Cleared on Mar 7, 2023 as substantially equivalent to K192282 (Medcad, 2020) after a 159-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Mar 7, 2023
- Review
- 159 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). No later device cites it as a predicate yet.
- 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 backK192282 MedCAD® AccuPlan® SystemMedcad · 2020
- This deviceK223024 MedCAD AccuPlan SystemMedcad · 2023
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 | K192282 | MedCAD® AccuPlan® System | Medcad | 2020 | — |
| 0 (this device) | K223024 | MedCAD AccuPlan System | Medcad | 2023 | — |
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 |
|---|---|---|---|
| * | K192282 | MedCAD® AccuPlan® SystemSummary page 4…ents and Accessories Regulation Number: 872.4120 Product Code: Primary – DZJ; Secondary – LLZ Classification Panel: Dental Predicate Device(s) MedCAD® AccuPlan® System (K192282) Reference Device(s) KLS Martin Individual Patient Solutions (IPS) Planning System (K181241) MedCAD® AccuShape® Titanium Patient… | 2020 |
| † | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | 2018 |
| † | K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | 2022 |
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 30 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 1 other device also cites its predicate K192282.
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. 2023, 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?
The MedCAD® AccuPlan® 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 MedCAD® AccuPlan® System and the result is an output data file that 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…
Read the full statement (125 words)
The MedCAD® AccuPlan® 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 MedCAD® AccuPlan® System and the result is an output data file that 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, and dental splints for use in maxillofacial surgery. The surgical guides and dental splints are intended to be used for the maxillofacial bone in maxillofacial surgery. The MedCAD® AccuPlan® System 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/K223024 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223024: MedCAD AccuPlan System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223024
Report an extraction error
Are you the manufacturer?
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