# K042030: Hyprocure Subtalar Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Graham Medical Technologies, LLC
- Decided: Sep 16, 2004 after 50 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
No predicates in its family tree.
10 later devices descend from it; 5 cite it directly.
0 of 11 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
- K103183: Trilliant Surgical Subtalar Implant (2011), 4 descendants of its own
- K111834: Disco Subtalar Implant (2011), 3 descendants of its own
- K142534: HyProCure II (2014), 2 descendants of its own
- K133035: Normed Pellegrin Calcaneus Stop Screw (2013), 2 descendants of its own
- K251382: Phoenix Sinus Tarsi Stent System (2025), 0 descendants of its own

## Indications for use
The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

Source page: https://510kreport.com/device/K042030
Methodology: https://510kreport.com/methodology