510(k) · Cleared
ClearedATLAS™ Expandable Osteotomy Wedge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MiRus, LLC · PLF Bone Wedge
Cleared on Feb 19, 2026 as substantially equivalent to K162241 (Paragon 28, 2017) and 1 other predicate after a 175-day review. Its family tree reaches back 6 generations to 2010.
- Decided
- Feb 19, 2026
- Review
- 175 days
- Class
- Class II
- Product code
- PLF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K093950 (2010). 13 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 backK201314 Restor3d Utility WedgeRestor3D, Inc. · 2021
- This deviceK252733 ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC · 2026
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 | K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (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.
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 16 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 1 other device also cites its predicate K162241.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 ATLAS TM Expandable Osteotomy Wedge System is an expandable osteotomy wedge fusion device used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle.
The ATLAS TM Expandable Osteotomy Wedge System is intended for use with supplemental fixation for use in the foot or ankle.
The ATLAS TM Expandable Osteotomy Wedge System is not intended for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252733 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252733: ATLAS™ Expandable Osteotomy Wedge System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252733
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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