510(k) · Cleared
ClearedPatient Specific Marking Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Additive Orthopaedics, LLC · PBF Orthopaedic Surgical Planning And Instrument Guides
Cleared on Jun 28, 2022 as substantially equivalent to K190044 (3D Systems, Inc., 2019) after a 442-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Jun 28, 2022
- Review
- 442 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K190044 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK190044 VSP Orthopedics System3D Systems, Inc. · 2019
- This deviceK211076 Patient Specific Marking GuidesAdditive Orthopaedics, LLC · 2022
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) | K211076 | Patient Specific Marking Guides | Additive Orthopaedics, LLC | 2022 | — |
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…21 CFR 888.3030 Product Code: PBF 4. PREDICATE DEVICES Predicate Device: • VSP® Orthopedics System, 3D Systems, Inc. (K190044) Reference Device: • Patient Specific 3D Printed Bone Segments Additive Orthopaedics, LLC (K180239) • Vantage PSI Sys… | 2019 |
| † | K180239 | Additive Orthopaedics Patient Specific 3D Printed Bone Segments | 2018 |
| † | K193432 | Vantage PSI System | 2020 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K190044.
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. 2022, 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 Paragon 28 Patient Specific Marking Guide 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 foot and ankle. The Patient Specific Guide is not intended to directly guide the cutting of bone. The device is single use only.
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/K211076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211076: Patient Specific Marking Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211076
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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