510(k) · Cleared
ClearedOsteotomy Truss System (OTS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
4Web, Inc. · HRS Plate, Fixation, Bone
Cleared on Feb 22, 2018 as substantially equivalent to K130185 (4-Web, Inc., 2013) and 1 other predicate after a 206-day review. Its family tree reaches back 4 generations to 2010. 10 later devices descend from it.
- Decided
- Feb 22, 2018
- Review
- 206 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K093950 (2010). 8 ancestors in all, the oldest K070525 (2007). 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK093950 Biofoam Bone Wedge Model AssortedWrightmedicaltechnologyinc · 2010
- 3 generations backK140531 Biofoam Bone WedgeWrightmedicaltechnologyinc · 2014
- 2 generations backK142724 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2015
- 1 generation backK152062 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2016
- This deviceK172294 Osteotomy Truss System (OTS)4Web, Inc. · 2018
- 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 · cites it directly · 1 of its ownK220463 Osteotomy Truss System (OTS)4Web Medical, Inc. · 2022
- Descendant · 2 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- 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
- K220463Osteotomy Truss System (OTS)4Web Medical, Inc. · 2022 · cites it directly1descendant
- K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K093950 | Biofoam Bone Wedge Model Assorted | Wrightmedicaltechnologyinc | 2010 | — |
| −3 | K140531 | Biofoam Bone Wedge | Wrightmedicaltechnologyinc | 2014 | — |
| −2 | K142724 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2015 | — |
| −1 | K152062 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2016 | — |
| 0 (this device) | K172294 | Osteotomy Truss System (OTS) | 4Web, Inc. | 2018 | — |
| +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 | — |
| +1 | K220463 | Osteotomy Truss System (OTS) | 4Web Medical, Inc. | 2022 | — |
| +2 | K252733 | ATLAS™ Expandable Osteotomy Wedge System | MiRus, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K130185 | 4WEB Osteotomy Bone WedgeSummary page 5…Page 2/2 Predicate Device(s): The Osteotomy Truss System is substantially equivalent to the primary predicate, which is the previously cleared 4WEB Osteotomy Bone Wedge (K130185). An additional predicate device is K152062, BIOFOAM Bone Wedge. Non-clinical testing: ASTM F2077 – Static and dynamic axial com… | 2013 |
| * | K152062 | BIOFOAM Bone WedgeSummary page 5…Truss System is substantially equivalent to the primary predicate, which is the previously cleared 4WEB Osteotomy Bone Wedge (K130185). An additional predicate device is K152062, BIOFOAM Bone Wedge. Non-clinical testing: ASTM F2077 – Static and dynamic axial compression ASTM F2119 – MR Image Artifact ASTM… | 2016 |
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K201314 (Restor3D, Inc., 2021) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K130185.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Osteotomy Truss System (OTS) is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:
- Opening wedge osteotomies of the bones of the foot including osteotomies for HalluxValgus
- Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- Metatarsal Cuneiform osteotomies
- Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies(TMT or Lapidus)
- Hindfoot osteotomies
These devices are intended to be used with supplemental fixation.
The Osteotomy Truss System is not intended for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172294: Osteotomy Truss System (OTS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172294
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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