510(k) · Cleared
ClearedADI TiDAL Osteotomy Wedge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Additive Device, Inc. (Adi) D/B/A Restor3D · PLF Bone Wedge
Cleared on Nov 5, 2019 as substantially equivalent to K131360 (Ascension Orthopedic, 2013) after a 200-day review. Its family tree reaches back 2 generations to 2010. 8 later devices descend from it.
- Decided
- Nov 5, 2019
- Review
- 200 days
- Class
- Class II
- Product code
- PLF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K093950 (2010). 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK093950 Biofoam Bone Wedge Model AssortedWrightmedicaltechnologyinc · 2010
- 1 generation backK131360 Integra Titanium Bone WedgeAscension Orthopedic · 2013
- This deviceK191047 ADI TiDAL Osteotomy WedgeAdditive Device, Inc. (Adi) D/B/A Restor3D · 2019
- Descendant · cites it directly · 7 of its ownK201314 Restor3d Utility WedgeRestor3D, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK220197 Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK243231 Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024
- Descendant · 2 generations on · 0 of its ownK252733 ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK252254 Osteotomy Wedge SystemSinaptic Surgical · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K201314Restor3d Utility WedgeRestor3D, Inc. · 2021 · cites it directly7descendants
- K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022 · 2 generations on4descendants
- K243231Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024 · 3 generations on1descendant
- K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC · 2026 · 2 generations on0descendants
- K252254Osteotomy Wedge SystemSinaptic Surgical · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K093950 | Biofoam Bone Wedge Model Assorted | Wrightmedicaltechnologyinc | 2010 | — |
| −1 | K131360 | Integra Titanium Bone Wedge | Ascension Orthopedic | 2013 | — |
| 0 (this device) | K191047 | ADI TiDAL Osteotomy Wedge | Additive Device, Inc. (Adi) D/B/A Restor3D | 2019 | — |
| +1 | K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021 | — |
| +2 | K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022 | — |
| +3 | K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024 | — |
| +2 | K252733 | ATLAS™ Expandable Osteotomy Wedge System | MiRus, LLC | 2026 | — |
| +2 | K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 PLF? 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 PLF device
- #1 K193414 Trigon HA Stand-Alone Wedge Fixation Systemscore 17.8 · 14 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 |
|---|---|---|---|
| * | K131360 | Integra Titanium Bone WedgeSummary page 4…fication: Orthopedic, Bone Wedge (Class II) 21 CFR 888.3030 E. Predicate Device(s): Integra Titanium Bone Wedge®, K131360 F. Physical Description: The proposed ADI TiDAL Osteotomy Wedge is a sterile, single use medical gra… | 2013 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201314 | Restor3d Utility Wedge | 2021 | 7 |
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 9 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K201314 (Restor3D, Inc., 2021) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K131360.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PLF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLF
30in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLF
2in 2025
MAUDE reports naming product code PLF, 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 3 | 30 | 0 | 3 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The TiDAL Osteotomy Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
Cotton (opening wedge) osteotomies of the medial cuneiform
Evans lengthening osteotomies.
The TiDAL Osteotomy Wedges are intended for use with ancillary plating fixation.
The TiDAL Osteotomy Wedges are not intended for use in the spine.
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/K191047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191047: ADI TiDAL Osteotomy Wedge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191047
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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