# K140689: Iknee Distal Femoral Cutting Guide

- Pathway: 510(k) (Traditional)
- Applicant: Evergreen Orthopedic Research Lab
- Decided: Aug 22, 2014 after 156 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: 3 generations back to K022126 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052425: Zimmer Computer Assisted Solutions-Electromagnetic and Imageless Knee Instrumentation, Zimmer, Inc. (2005) Summary page 4.
- K010204: Stryker Navigation System-Knee Module, Stryker Corp. (2001) Summary page 4.

## Indications for use
The iKnee Distal Femoral Cutting Guide is indicated for use as a stereotaxic accessory instrument that acts as a cutting guide for the distal femur during a total knee arthroplasty using computer navigation. The iKnee Distal Femoral Cutting Guide requires the use of a Stryker Smart Instrument navigation tracker in conjunction with a compatible Stryker navigation system.

Source page: https://510kreport.com/device/K140689
Methodology: https://510kreport.com/methodology