# K991313: Accutred Shoe

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Technology Research, Inc.
- Decided: Jun 23, 1999 after 68 days
- Product code: IRN (Device, Warning, Overload, External Limb, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5575
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K023161: Smartstep System (2002), 1 descendant of its own
- K060150: Smartstep System/Smarstep Clinic System (2006), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K991313
Methodology: https://510kreport.com/methodology