# K111265: Metasurg Subtalar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Metasurg
- Decided: Aug 9, 2011 after 97 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.
2 later devices descend from it; 2 cite 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. The FDA summary names no predicate by number.

## Most influential descendants
- K210016: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System (2021), 0 descendants of its own
- K140962: Normed Vario Subtalar Screw (2014), 0 descendants of its own

## Indications for use
The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Indications include: * Severe pronation * Calcaneal valgus deformity * Plantarfiexed talus * Failed correction with long term orthotic treatment * Congenital and painful flatfoot deformity * Repair of tarsal coalitions * Subtalar instability * Posterior tibial tendon dysfunction * Paralytic flat foot deformity The Metasurg subtalar implants are intended for single use only.

Source page: https://510kreport.com/device/K111265
Methodology: https://510kreport.com/methodology