# K200124: InCore MPJ System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: May 13, 2020 after 113 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: 9 generations back to K962823 (1996). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121417: XMCP, Hallux, Tarsx, Extremity Medical Screw System, Extremity Medical, LLC (2012) Summary page 4.
- K180257: InCore® Lapidus System, Nextremity Solutions, Inc. (2018) Summary page 4.
- K192578: InCore TMT System, Nextremity Solutions, Inc. (2019) Summary page 4.

## Indications for use
The Nextremity Solutions InCore® MPJ System is a three-part construct intended for internal fixation for First Metatarsophalangeal Joint Arthrodesis (also known as 1st MPJ Fusion).

Source page: https://510kreport.com/device/K200124
Methodology: https://510kreport.com/methodology