# K022579: Stryker Navigation System-Knee Module

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger
- Decided: Jun 2, 2003 after 301 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
49 later devices descend from it; 3 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Image guided surgery systems marketed by Stryker, Medtronic, Brainlab, and Aesculap: named in the summary without a submission number

## Most influential descendants
- K141941: Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap  3D 3.0-Enable, Spinemap  3D 3.0-Sales D (2014), 22 descendants of its own
- K100742: Exactech GPS (2010), 20 descendants of its own
- K152764: Exactech GPS (2016), 19 descendants of its own
- K153240: Styrker OrthoMap Express Knee System (2016), 17 descendants of its own
- K162341: Stryker OrthoMap Precision Knee system (2016), 16 descendants of its own

## Recalls of this device
- Jun 5, 2008 · Not classified · Z-2288-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2294-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2291-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2289-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2292-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2293-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
- Jun 5, 2008 · Not classified · Z-2290-2008: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.

## Indications for use
The Stryker Navigation System - Knee Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.

Source page: https://510kreport.com/device/K022579
Methodology: https://510kreport.com/methodology