# K110054: Navitrack System - OS Knee Universal, Cas Same Incision Tibia Reference

- Pathway: 510(k) (Special)
- Applicant: Zimmer Cas
- Decided: Mar 24, 2011 after 76 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002053 (2000). 5 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060336: Navitrack System-OS Knee Universal, Model Pro-05002, Orthosoft, Inc. (2006) Summary page 1.

## Most influential descendants
- K202750: Knee+ (2021), 8 descendants of its own
- K220104: Knee+ (2022), 7 descendants of its own
- K230789: Knee+ (2023), 5 descendants of its own
- K233899: Knee+ (2024), 4 descendants of its own
- K243975: Knee+ (2025), 3 descendants of its own

## Recalls of this device
- Jan 7, 2022 · Class II · Z-0721-2022: The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading t
- Oct 6, 2011 · Class II · Z-1881-2017: Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.

## Indications for use
The Navitrack® System - OS Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intra-operatively. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

Source page: https://510kreport.com/device/K110054
Methodology: https://510kreport.com/methodology