# K213301: InCore Subtalar System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: Dec 21, 2021 after 81 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: 5 generations back to K922322 (1992). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140891: Biomet Cannulated Screw System, Biomet, Inc. (2014) Summary page 4.
- K182201: Stratum™ Foot Plating System, Nextremity Solutions, Inc. (2018) Summary page 4.

## Indications for use
The Nextremity Solutions InCore® Subtalar System is intended for reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the foot. The three-part construct is specifically intended for internal fixation for Subtalar Joint Arthodesis (also known as Subtalar Joint Fusion).

Source page: https://510kreport.com/device/K213301
Methodology: https://510kreport.com/methodology