510(k) · Cleared
ClearedAccutred Shoe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopedic Technology Research, Inc. · IRN Device, Warning, Overload, External Limb, Powered
Cleared on Jun 23, 1999 after a 68-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jun 23, 1999
- Review
- 68 days
- Class
- Class II
- Product code
- IRN
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK991313 Accutred ShoeOrthopedic Technology Research, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK023161 Smartstep SystemAndante Medical Device, Ltd. · 2002
- Descendant · 2 generations on · 0 of its ownK060150 Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991313 | Accutred Shoe | Orthopedic Technology Research, Inc. | 1999 | — |
| +1 | K023161 | Smartstep System | Andante Medical Device, Ltd. | 2002 | — |
| +2 | K060150 | Smartstep System/Smarstep Clinic System | Andante Medical Devices, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023161 | Smartstep System | 2002 | 1 |
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?
- Of its descendants, K023161 (Andante Medical Device, Ltd., 2002) has gone furthest, with 1 descendant of its own.
How does its category compare?
All IRN devicesIRN Device, Warning, Overload, External Limb, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IRN
FDA has decided no IRN device since 2007.
Median 510(k) review, days · IRN
Too few IRN 510(k)s in any year since 2007 to give a median.
Recalls per year · IRN
No recall names IRN since 2007.
Adverse event reports per year · IRN
No MAUDE report names IRN 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 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AccuTread™ Shoe System is intended for use as a limb load monitoring device to monitor limited weight bearing during rehabilitation of patients with insults to their lower extremities. Furthermore, the AccuTread™ Shoe System is intended to be used in any situation in which a therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991313 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991313: Accutred Shoe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991313
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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