# K111799: Nugait (TM) Subtalar Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedic
- Decided: Aug 19, 2011 after 53 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K792670 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080280: Sub-Talar Lok, Model 7-11 MM, Instratek, Inc. (2008) Summary page 1.

## Indications for use
The NuGait Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System is intended for the following pathological conditions resulting from disease, injury, or other trauma: * Hypermobile pes valgus; * Posterior tibial tendon dysfunction; * Severe pronation; * Subtalar instability; * Hypermobile flexible congenital flat foot. The NuGait Subtalar Implant System implants are intended for single use only.

Source page: https://510kreport.com/device/K111799
Methodology: https://510kreport.com/methodology