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, Inc. · PBF Orthopaedic Surgical Planning And Instrument Guides
Cleared on Aug 21, 2019 after a 224-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 12 later devices descend from it.
- Decided
- Aug 21, 2019
- Review
- 224 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
12 later devices descend from it, 4 citing it directly.
- This deviceK190044 VSP Orthopedics System3D Systems, Inc. · 2019
- Descendant · cites it directly · 6 of its ownK211244 VSP® Orthopedics System3D Systems · 2021
- Descendant · 2 generations on · 3 of its ownK220717 RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC · 2022
- Descendant · 3 generations on · 2 of its ownK241811 MedCAD® AccuStride™ SystemMedcad · 2025
- Descendant · cites it directly · 1 of its ownK220706 MyPAO GuidesMedacta International S.A. · 2023
- Descendant · cites it directly · 1 of its ownK212237 3D-Cut3D-Side S.A. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K211244VSP® Orthopedics System3D Systems · 2021 · cites it directly6descendants
- K220717RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC · 2022 · 2 generations on3descendants
- K241811MedCAD® AccuStride™ SystemMedcad · 2025 · 3 generations on2descendants
- K220706MyPAO GuidesMedacta International S.A. · 2023 · cites it directly1descendant
- K2122373D-Cut3D-Side S.A. · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190044 | VSP Orthopedics System | 3D Systems, Inc. | 2019 | — |
| +1 | K211244 | VSP® Orthopedics System | 3D Systems | 2021 | — |
| +2 | K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | 2022 | — |
| +3 | K241811 | MedCAD® AccuStride™ System | Medcad | 2025 | — |
| +1 | K220706 | MyPAO Guides | Medacta International S.A. | 2023 | — |
| +1 | K212237 | 3D-Cut | 3D-Side S.A. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 4 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K173167 | SurgiCase Orthopedics System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (12)
See all 124 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?
- Of its descendants, K211244 (3D Systems, 2021) has gone furthest, with 6 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. 2019, 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/K190044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190044: 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/K190044
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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