# K180257: InCore® Lapidus System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: Apr 25, 2018 after 85 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: 7 generations back to K962823 (1996). 38 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 42 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.
- K160304: OsteoBullet Compression Screw, Phalanx Innovations (2016) Summary page 4.

## Most influential descendants
- K192578: InCore TMT System (2019), 1 descendant of its own
- K200124: InCore MPJ System (2020), 0 descendants of its own
- K190231: InCore® Lapidus Sterile Kits (2019), 0 descendants of its own

## 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/K180257
Methodology: https://510kreport.com/methodology