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 Medical, Inc. · HRS Plate, Fixation, Bone
Cleared on Nov 1, 2024 as substantially equivalent to K220463 (4Web Medical, Inc., 2022) after a 267-day review. Its family tree reaches back 6 generations to 2010.
- Decided
- Nov 1, 2024
- Review
- 267 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K093950 (2010). 10 ancestors in all, the oldest K070525 (2007). No later device cites it as a predicate yet.
- Root · 6 generations backK093950 Biofoam Bone Wedge Model AssortedWrightmedicaltechnologyinc · 2010
- 5 generations backK140531 Biofoam Bone WedgeWrightmedicaltechnologyinc · 2014
- 4 generations backK142724 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2015
- 3 generations backK152062 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2016
- 2 generations backK172294 Osteotomy Truss System (OTS)4Web, Inc. · 2018
- 1 generation backK220463 Osteotomy Truss System (OTS)4Web Medical, Inc. · 2022
- This deviceK240388 Osteotomy Truss System (OTS)4Web Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K093950 | Biofoam Bone Wedge Model Assorted | Wrightmedicaltechnologyinc | 2010 | — |
| −5 | K140531 | Biofoam Bone Wedge | Wrightmedicaltechnologyinc | 2014 | — |
| −4 | K142724 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2015 | — |
| −3 | K152062 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2016 | — |
| −2 | K172294 | Osteotomy Truss System (OTS) | 4Web, Inc. | 2018 | — |
| −1 | K220463 | Osteotomy Truss System (OTS) | 4Web Medical, Inc. | 2022 | — |
| 0 (this device) | K240388 | Osteotomy Truss System (OTS) | 4Web Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K220463 | Osteotomy Truss System (OTS)Summary page 6…a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. Predicate Device(s): The primary predicate device is the 4WEB Medical Osteotomy Truss System (K220463). Performance Standards: Engineering analysis, static axial compression testing per ASTM F2077, and dynamic axial compression te… | 2022 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Hallux Valgus
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
The device is intended for use with supplemental fixation.
The Osteotomy Truss System 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/K240388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240388: 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/K240388
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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