# K162341: Stryker OrthoMap Precision Knee system

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Oct 12, 2016 after 51 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: 4 generations back to K993239 (2000). 9 ancestors in all.
16 later devices descend from it; 4 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)
- K153240: Styrker OrthoMap Express Knee System, Stryker Corporate (2016) Summary page 4.

## Most influential descendants
- 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
- K241171: Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (2024), 4 descendants of its own

## Indications for use
The Stryker OrthoMap Precision Knee system, which is comprised of the OrthoMap Precision Knee 5.0 Software and a platform of the NAV3i platform family, is intended as a planning and intraoperative 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/K162341
Methodology: https://510kreport.com/methodology