# K190231: InCore® Lapidus Sterile Kits

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: May 24, 2019 after 107 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.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180257: InCore® Lapidus System, Nextremity Solutions, Inc. (2018) Summary page 4.

## Indications for use
The Nextremity Solutions InCore® Lapidus System is a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion).

Source page: https://510kreport.com/device/K190231
Methodology: https://510kreport.com/methodology