510(k) · Cleared
Cleared4WEB Osteotomy Bone Wedge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
4-Web, Inc. · HRS Plate, Fixation, Bone
Cleared on Jun 7, 2013 as substantially equivalent to K073535 (Wrightmedicaltechnologyinc, 2008) after a 133-day review. Its family tree reaches back 1 generation to 2008. 14 later devices descend from it.
- Decided
- Jun 7, 2013
- Review
- 133 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K073535 (2008). 14 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK073535 Biofoam Bone WedgeWrightmedicaltechnologyinc · 2008
- This deviceK130185 4WEB Osteotomy Bone Wedge4-Web, Inc. · 2013
- Descendant · cites it directly · 10 of its ownK172294 Osteotomy Truss System (OTS)4Web, Inc. · 2018
- 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 · cites it directly · 2 of its ownK162241 TITAN 3-D™ Wedge SystemParagon 28 · 2017 · Recalled
- Descendant · 4 generations on · 1 of its ownK243231 Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K172294Osteotomy Truss System (OTS)4Web, Inc. · 2018 · cites it directly10descendants
- K201314Restor3d Utility WedgeRestor3D, Inc. · 2021 · 2 generations on7descendants
- K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022 · 3 generations on4descendants
- K162241TITAN 3-D™ Wedge SystemParagon 28 · 2017 · cites it directly2descendants
- K243231Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K073535 | Biofoam Bone Wedge | Wrightmedicaltechnologyinc | 2008 | — |
| 0 (this device) | K130185 | 4WEB Osteotomy Bone Wedge | 4-Web, Inc. | 2013 | — |
| +1 | K172294 | Osteotomy Truss System (OTS) | 4Web, Inc. | 2018 | — |
| +2 | K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021 | — |
| +3 | K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022 | — |
| +1 | K162241 | TITAN 3-D™ Wedge System | Paragon 28 | 2017 | 1 |
| +4 | K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K073535 | Biofoam Bone WedgeSummary page 1…low {6Al4V-ELI) per ASTM F-136/ISO 5832-3. Predicate Device(s): The 4Web Osteotomy Bone Wedge is substantially equivalent to the Biofoam Bone Wedge from Wright Medical (K073535). Performance Standards: The pre-clinical testing performed includes static and dynamic compression testing per ASTM F2077-11 a… | 2008 |
What descends from it? (14)
See all 145 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 4Web Osteotomy Bone Wedge is intended to be used for internal bone fixation or osteotomies in the foot, such as:
1. Opening wedge osteotomies of Hallux Valgus
2. Cotton opening wedge osteotomies
3. Evans lengthening osteotomies
These devices are intended to be used with autograft bone and ancillary fixation.
The 4Web Osteotomy Bone Wedge is 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/K130185 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130185: 4WEB Osteotomy Bone Wedge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130185
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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