510(k) · Cleared
ClearedTrexo Theo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trexo Robotics, Inc. · PHL Powered Exoskeleton
Cleared on Sep 2, 2026 as substantially equivalent to K233695 (Cyberdyne, Inc., 2024) and 1 other predicate after a 253-day review. Its family tree reaches back 4 generations to 2014.
- Decided
- Sep 2, 2026
- Review
- 253 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN130034 (2014). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- 3 generations backK171909 HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc. · 2017
- 2 generations backK201559 HAL for Medical Use (Lower Limb type)Cyberdyne, Inc. · 2020
- 1 generation backK233695 Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc. · 2024
- This deviceK254198 Trexo TheoTrexo Robotics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN130034 | Rewalk | Argo Medical Technologies, Inc. | 2014 | — |
| −3 | K171909 | HAL for Medical Use (Lower Limb Type) | Cyberdyne, Inc. | 2017 | — |
| −2 | K201559 | HAL for Medical Use (Lower Limb type) | Cyberdyne, Inc. | 2020 | — |
| −1 | K233695 | Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne, Inc. | 2024 | — |
| 0 (this device) | K254198 | Trexo Theo | Trexo Robotics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 PHL? 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 PHL device
- #1 K250904 Atalante Xscore 15.0 · 7 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 |
|---|---|---|---|
| * | K233695 | Medical HAL Lower Limb Type (HAL-ML)Summary page 5…me Manufacturer 510(k) Medical HAL Lower Limb Type (HAL-ML) Cyberdyne Inc. K233695 Rewalk P6.0 Rewalk Robotics Ltd. K221696 4. Indications for Use Statement Th… | 2024 |
| * | K221696 | ReWalk P6.0Summary page 5…ical HAL Lower Limb Type (HAL-ML) Cyberdyne Inc. K233695 Rewalk P6.0 Rewalk Robotics Ltd. K221696 4. Indications for Use Statement The Trexo Theo is a powered exoskeleton intended to perform ambulatory functions in patients… | 2023 |
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 12 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PHL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHL
177in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHL
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHL
6in 2025
MAUDE reports naming product code PHL, 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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 4 | 145 | 0 | 4 |
| 2017 | 2 | — | 1 | 8 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 4 | 110 | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 3 | 177 | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Trexo Theo is a powered exoskeleton intended to perform ambulatory functions in patients 12 years and older with cerebral palsy.
The Trexo Theo is intended to be used in a community setting under the supervision of a trained companion who has been certified to the companion training program prior to use of the device. The device is also intended to be used in a clinical setting under the supervision of a trained therapist who has been certified to the therapist training program prior to use of the device.
The Trexo Theo is not intended for sports or stair climbing.
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/K254198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254198: Trexo Theo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254198
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026