510(k) · Cleared
ClearedVSP® Orthopedics System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Systems · PBF Orthopaedic Surgical Planning And Instrument Guides
Cleared on Nov 10, 2021 as substantially equivalent to K190044 (3D Systems, Inc., 2019) after a 198-day review. Its family tree reaches back 1 generation to 2019. 6 later devices descend from it.
- Decided
- Nov 10, 2021
- Review
- 198 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K190044 (2019). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK190044 VSP Orthopedics System3D Systems, Inc. · 2019
- This deviceK211244 VSP® Orthopedics System3D Systems · 2021
- Descendant · cites it directly · 3 of its ownK220717 RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC · 2022
- Descendant · 2 generations on · 2 of its ownK241811 MedCAD® AccuStride™ SystemMedcad · 2025
- Descendant · 3 generations on · 0 of its ownK252064 MedCAD® AccuStride™ SystemMedcad · 2026
- Descendant · cites it directly · 0 of its ownK250711 VSP Orthopedics System3D Systems, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK251709 MedCAD® AccuStride™ SystemMedcad · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K220717RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC · 2022 · cites it directly3descendants
- K241811MedCAD® AccuStride™ SystemMedcad · 2025 · 2 generations on2descendants
- K252064MedCAD® AccuStride™ SystemMedcad · 2026 · 3 generations on0descendants
- K250711VSP Orthopedics System3D Systems, Inc. · 2025 · cites it directly0descendants
- K251709MedCAD® AccuStride™ SystemMedcad · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K190044 | VSP Orthopedics System | 3D Systems, Inc. | 2019 | — |
| 0 (this device) | K211244 | VSP® Orthopedics System | 3D Systems | 2021 | — |
| +1 | K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | 2022 | — |
| +2 | K241811 | MedCAD® AccuStride™ System | Medcad | 2025 | — |
| +3 | K252064 | MedCAD® AccuStride™ System | Medcad | 2026 | — |
| +1 | K250711 | VSP Orthopedics System | 3D Systems, Inc. | 2025 | — |
| +3 | K251709 | MedCAD® AccuStride™ System | Medcad | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 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 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 |
|---|---|---|---|
| * | K190044 | VSP Orthopedics SystemSummary page 4…Classification: Class II, 21 CFR 888.3030 Product Code: PBF 4. PREDICATE DEVICES Predicate device: VSP® Orthopedics System, 3D Systems (K190044) 5. DESCRIPTION OF THE DEVICE The VSP® Orthopedics System is intended to assist a surgeon with pre‐operative planning and t… | 2019 |
What descends from it? (6)
3 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?
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. 2021, 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 VSP® Orthopedics 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 in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the distal femur, tibia, and non-sacrum pelvis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211244: VSP® 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/K211244
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