# K153240: Styrker OrthoMap Express Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporate
- Decided: Jul 7, 2016 after 241 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 K993239 (2000). 8 ancestors in all.
17 later devices descend from it; 2 cite 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)
- K022579: Stryker Navigation System-Knee Module, Stryker Leibinger (2003) Summary page 4.
- K141551: Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees), Stryker Corporate (2014) Summary page 5.
- K130874: Stryker NAV3I Platform, Stryker Corporate (2013) Summary page 5.
- K150301: NavSuite3 Kit, Stryker Leibinger GmbH & Co. KG - Navigation (2015) Summary page 5.

## Most influential descendants
- K162341: Stryker OrthoMap Precision Knee system (2016), 16 descendants of its own
- K172034: Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap (2017), 12 descendants of its own
- K220593: Spine Guidance Software, Stryker Q Guidance System (2022), 10 descendants of its own
- K203205: Navigated Spine Instruments (2021), 8 descendants of its own
- K240662: Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece (2024), 7 descendants of its own

## Indications for use
The Stryker OrthoMap Express Knee system, which is comprised of the OrthoMap Express Knee 2.0 Software and a platform of the NAV3i platform family, is intended as a planning and intra-operative guidance system to enable open or percutaneous image-guided surgery. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. 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/K153240
Methodology: https://510kreport.com/methodology