# K190670: ORTHOLOC™ 2 Lapidus with Rotation System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 14, 2019 after 60 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K022325 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120359: Ortholoc 3DI Hallux System, Wrightmedicaltechnologyinc (2012) Summary page 4.

## Indications for use
The ORTHOLOC™ 2 Lapidus with Rotation System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include: Arthrodesis of the first metatarsal-cuneiform joint (Lapidus Fusion).

Source page: https://510kreport.com/device/K190670
Methodology: https://510kreport.com/methodology