510(k) · Cleared
ClearedxStep (xStep)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinex, Inc. · SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Cleared on Apr 20, 2026 as substantially equivalent to DEN240014 (Onward Medical, Inc., 2024) after a 152-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Apr 20, 2026
- Review
- 152 days
- Class
- Class II
- Product code
- SDO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN240014 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN240014 ARC-EX SystemOnward Medical, Inc. · 2024
- This deviceK253638 xStep (xStep)Spinex, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN240014 | ARC-EX System | Onward Medical, Inc. | 2024 | — |
| 0 (this device) | K253638 | xStep (xStep) | Spinex, Inc. | 2026 | — |
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 SDO? 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 SDO device
- #1 K252893 ExaStim® Stimulation System (EXA-001)…score 11.1 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | DEN240014 | ARC-EX SystemSummary page 5…Class II Regulation Number 21 CFR 890.5851 3. Predicate Device Predicate Manufacturer: Onward Medical Predicate Device: ARCEX 510(k) Number: DEN240014 4. Device Description The xStep™ is a medical device intended to deliver programmed transcutaneous electrical spinal cord stimul… | 2024 |
| † | K132422 | Pals Platinum Neurostimulation Electrodes | 2014 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN240014.
How does its category compare?
All SDO devicesSDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SDO
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SDO
Too few SDO 510(k)s in any year since 2007 to give a median.
Recalls per year · SDO
No recall names SDO since 2007.
Adverse event reports per year · SDO
No MAUDE report names SDO since 2007.
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 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The xStep TM is intended to deliver programmed transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive). The xStepTM device is for prescription use in patients ages 18-75 years old in a medical center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253638 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253638: xStep (xStep).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253638
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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