# K210653: ONE Planner Hip

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft D/B/A Zimmer Cas
- Decided: Jul 7, 2021 after 125 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K810258 (1981). 180 ancestors in all.
No later device cites it as a predicate yet.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192656: Optimized Positioning System (OPS) Insight, Corin USA (2020) Summary page 4.

## Indications for use
ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

Source page: https://510kreport.com/device/K210653
Methodology: https://510kreport.com/methodology