# K212979: CalcShift™ Displacement Calcaneal Osteotomy System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: May 20, 2022 after 245 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: 10 generations back to K954385 (1996). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121651: Ortholoc 3DI Midfoot/Flatfoot System, Wrightmedicaltechnologyinc (2012) Summary page 4.
- K182201: Stratum™ Foot Plating System, Nextremity Solutions, Inc. (2018) Summary page 4.
- K140891: Biomet Cannulated Screw System, Biomet, Inc. (2014) Summary page 4.

## Indications for use
The Nextremity Solutions CalcShift™ Displacement Calcaneal Osteotomy System is indicated for osteotomies, non-unions, malunions, revisions, fusions, and reconstruction of the calcaneus requiring a medial or lateral displacement osteotomy.

Source page: https://510kreport.com/device/K212979
Methodology: https://510kreport.com/methodology