# K193094: Naviswiss Hip Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Naviswiss AG
- Decided: Jun 10, 2020 after 216 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K010612 (2001). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162364: Intellijoint HIP Generation 2A System, Intellijoint Surgical, Inc. (2017) Summary page 4.

## Most influential descendants
- K223351: Naviswiss Knee (2023), 0 descendants of its own

## Indications for use
The Naviswiss Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system is only compatible with acetabular cup impactors that have a parallel and straight segment. The system aids the surgeon in performing intra-operative measurements including measurements of leg length, offset, and cup inclination/anteversion. An example of a stereotaxic orthopedic surgical procedure includes Total Hip Arthroplasty: Lateral/Supine. The equipment is intended for use by trained surgeons in operating theaters.

Source page: https://510kreport.com/device/K193094
Methodology: https://510kreport.com/methodology