# K223351: Naviswiss Knee

- Pathway: 510(k) (Traditional)
- Applicant: Naviswiss AG
- Decided: Jan 31, 2023 after 90 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: 12 generations back to K010612 (2001). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193094: Naviswiss Hip Navigation System, Naviswiss AG (2020) Summary page 4.
- K191507: Intellijoint® Navigation System, Intellijoint Surgical, Inc. (2019) Summary page 4.

## Indications for use
The Naviswiss Knee 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 aids the surgeon in performing intra-operative measurements of femoral and tibial alignment axes to assist in executing the distal femoral and proximal tibial resections. The equipment is intended for use by trained surgeons in operating theaters.

Source page: https://510kreport.com/device/K223351
Methodology: https://510kreport.com/methodology