# K192578: InCore TMT System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: Dec 31, 2019 after 103 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: 8 generations back to K962823 (1996). 39 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121349: IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer, Extremity Medical, LLC (2012) Summary page 4.
- K180257: InCore® Lapidus System, Nextremity Solutions, Inc. (2018) Summary page 4.

## Most influential descendants
- K200124: InCore MPJ System (2020), 0 descendants of its own

## Indications for use
The Nextremity Solutions InCore® TMT System is a three-part construct intended for internal fixation for Lesser Tarsometatarsal Joint Arthrodesis (also known as Lisfranc Joint Fusion or 2nd/3rd Tarsometatarsal Fusion).

Source page: https://510kreport.com/device/K192578
Methodology: https://510kreport.com/methodology