510(k) · Cleared
ClearedIntegra Titanium Bone Wedge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedic · HRS Plate, Fixation, Bone
Cleared on Aug 7, 2013 as substantially equivalent to K093950 (Wrightmedicaltechnologyinc, 2010) after an 86-day review. Its family tree reaches back 1 generation to 2010. 10 later devices descend from it.
- Decided
- Aug 7, 2013
- Review
- 86 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093950 (2010). 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK093950 Biofoam Bone Wedge Model AssortedWrightmedicaltechnologyinc · 2010
- This deviceK131360 Integra Titanium Bone WedgeAscension Orthopedic · 2013
- Descendant · cites it directly · 8 of its ownK191047 ADI TiDAL Osteotomy WedgeAdditive Device, Inc. (Adi) D/B/A Restor3D · 2019
- Descendant · 2 generations on · 7 of its ownK201314 Restor3d Utility WedgeRestor3D, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK220197 Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK243231 Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024
- Descendant · 3 generations on · 0 of its ownK252733 ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K191047ADI TiDAL Osteotomy WedgeAdditive Device, Inc. (Adi) D/B/A Restor3D · 2019 · cites it directly8descendants
- K201314Restor3d Utility WedgeRestor3D, Inc. · 2021 · 2 generations on7descendants
- K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022 · 3 generations on4descendants
- K243231Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024 · 4 generations on1descendant
- K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093950 | Biofoam Bone Wedge Model Assorted | Wrightmedicaltechnologyinc | 2010 | — |
| 0 (this device) | K131360 | Integra Titanium Bone Wedge | Ascension Orthopedic | 2013 | — |
| +1 | K191047 | ADI TiDAL Osteotomy Wedge | Additive Device, Inc. (Adi) D/B/A Restor3D | 2019 | — |
| +2 | K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021 | — |
| +3 | K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022 | — |
| +4 | K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024 | — |
| +3 | K252733 | ATLAS™ Expandable Osteotomy Wedge System | MiRus, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K093950 | Biofoam Bone Wedge Model AssortedSummary page 1…intended use to the predicate device detailed in the following table. 510(k) Numnber~ Product Code Trade Name Manufacturer K093950 HRS; HWC BIOFOAMTM Bone Wright Medical Wedge… | 2010 |
What descends from it? (10)
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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Integra® Titanium Bone 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 Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation.
The Integra® Titanium Bone Wedges are not intended for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131360: Integra Titanium Bone Wedge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131360
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