510(k) · Cleared
ClearedMedCAD AccuPlan Orthopedics System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcad · PBF Orthopaedic Surgical Planning And Instrument Guides
Cleared on Sep 20, 2023 as substantially equivalent to K211614 (Centermed, Inc., 2022) after a 314-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Sep 20, 2023
- Review
- 314 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K924630 (1993). 14 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 9 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations between
- 3 generations backK182789 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2019
- 2 generations backK192979 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2020
- 1 generation backK211614 CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc. · 2022
- This deviceK223421 MedCAD AccuPlan Orthopedics SystemMedcad · 2023
Show all 9 generations
- Root · 9 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 8 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 7 generations backK033849 Simplant SystemMaterialise NV · 2004
- 6 generations backK060950 3MATICMaterialise NV · 2006
- 5 generations backK120956 VSP SystemMedical Modeling, Inc. · 2012
- 4 generations backK181241 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2018
- 3 generations backK182789 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2019
- 2 generations backK192979 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2020
- 1 generation backK211614 CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc. · 2022
- This deviceK223421 MedCAD AccuPlan Orthopedics SystemMedcad · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −8 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −7 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −6 | K060950 | 3MATIC | Materialise NV | 2006 | — |
| −5 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
| −4 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2018 | — |
| −3 | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2019 | — |
| −2 | K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2020 | — |
| −1 | K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | 2022 | — |
| 0 (this device) | K223421 | MedCAD AccuPlan Orthopedics 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 PBF? 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 PBF device
- #1 K241811 MedCAD® AccuStride™ Systemscore 17.1 · 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 |
|---|---|---|---|
| * | K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemSummary page 4…gement and processing system Product Code: PBF, LLZ Classification Panel: Orthopedic Predicate Device CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K211614) Reference Devices MedCAD® AccuPlan® System (K192282 / K223024) Indications for Use: MedCAD® AccuPlan® Orthopedics System is in… | 2022 |
| † | K192282 | MedCAD® AccuPlan® System | 2020 |
| † | K223024 | MedCAD AccuPlan System | 2023 |
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 6 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All PBF devicesPBF Orthopaedic Surgical Planning And Instrument Guides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PBF
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBF
227in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBF
No recall names PBF since 2007.
Adverse event reports per year · PBF
62in 2025
MAUDE reports naming product code PBF, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 12 |
| 2022 | 3 | 435 | 0 | 53 |
| 2023 | 5 | 314 | 0 | 45 |
| 2024 | 3 | 62 | 0 | 34 |
| 2025 | 8 | 227 | 0 | 62 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
MedCAD® AccuPlan® Orthopedics 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 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 of…
Read the full statement (144 words)
MedCAD® AccuPlan® Orthopedics 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 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 of the fibula and ilium, surgical guides for harvesting bone grafts from the fibula or ilium, and surgical planning case reports for use in maxillofacial reconstructive surgeries. MedCAD® AccuPlan® Orthopedics System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. The MedCAD® AccuPlan® Orthopedics System is indicated for use in adolescents (greater than 12 to 21 years of age) and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223421: MedCAD AccuPlan Orthopedics System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223421
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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