510(k) · Cleared
ClearedMedCAD® AccuStride™ 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 Mar 13, 2025 as substantially equivalent to K220717 (Redpoint Medical, LLC, 2022) after a 265-day review. Its family tree reaches back 8 generations to 1993. 2 later devices descend from it.
- Decided
- Mar 13, 2025
- Review
- 265 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K924630 (1993). 14 ancestors in all, the oldest K924810 (1993). 2 later devices descend from it, 2 citing it directly.
- 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 backK073449 SurgicaseMaterialise NV · 2008
- 4 generations backK112389 Surgicase Connect, Surgicase GuideMaterialise NV · 2012
- 3 generations backK132290 Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV · 2014
- 2 generations backK163156 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV · 2017
- 1 generation backK220717 RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC · 2022
- This deviceK241811 MedCAD® AccuStride™ SystemMedcad · 2025
- Descendant · cites it directly · 0 of its ownK252064 MedCAD® AccuStride™ SystemMedcad · 2026
- Descendant · cites it directly · 0 of its ownK251709 MedCAD® AccuStride™ SystemMedcad · 2025
Most influential descendants
Showing 2 of 2 · See allView 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 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −4 | K112389 | Surgicase Connect, Surgicase Guide | Materialise NV | 2012 | — |
| −3 | K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides | Materialise NV | 2014 | — |
| −2 | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | Materialise NV | 2017 | — |
| −1 | K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | 2022 | — |
| 0 (this device) | K241811 | MedCAD® AccuStride™ System | Medcad | 2025 | — |
| +1 | K252064 | MedCAD® AccuStride™ System | Medcad | 2026 | — |
| +1 | K251709 | MedCAD® AccuStride™ System | Medcad | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 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 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 K250921 CORIOGRAPH Pre-Op Planning and Modeling Servicesscore 16.5 · 24 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 |
|---|---|---|---|
| * | K220717 | RedPoint Medical's Better Bunion SystemSummary page 5…Planning And Instrument Guides Regulation Number: 888.3030 Product Code: PBF Classification Panel: Orthopedic Predicate Device(s) RedPoint Medical Better Bunion System (K220717) Reference Device(s) MedCAD® AccuPlan® Orthopedics System (K223421) MedCAD® AccuPlan® System (K223024) Indications for Use: The… | 2022 |
| † | K223421 | MedCAD AccuPlan Orthopedics System | 2023 |
| † | K223024 | MedCAD AccuPlan System | 2023 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K252064 (Medcad, 2026) has gone furthest, with 0 descendants of its own.
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. 2025, 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?
The MedCAD® AccuStride™ System is intended to be used as a surgical instrument to assist in
preoperative planning and/or in guiding the marking of bone and/or guide surgical instruments in
non-acute, non-joint replacing osteotomies in the foot for adult and pediatric patients 12 years of age
and older. The MedCAD® AccuStride™ System surgical guides are intended for single use only.
The MedCAD® AccuStride™ System surgical guides should only be used when the anatomic
landmarks necessary for pre-operative planning can be clearly identified on the patient’s
radiographic images (i.e., CT).
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/K241811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241811: MedCAD® AccuStride™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241811
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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