# K211429: NAVIPLAN - CT Planning Software for Total Hip Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Naviswiss AG
- Decided: Oct 5, 2021 after 151 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: 9 generations back to K896095 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133022: Zedview, Lexi Co., Ltd. (2014) Summary page 5.

## Indications for use
Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants)

Source page: https://510kreport.com/device/K211429
Methodology: https://510kreport.com/methodology