# 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 - Pathway: 510(k) (Traditional) - Applicant: Stryker Corporation - Decided: Oct 18, 2017 after 105 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: 5 generations back to K993239 (2000). 13 ancestors in all. 12 later devices descend from it; 3 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) - K141941: Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap 3D 3.0-Enable, Spinemap 3D 3.0-Sales D, Stryker Corporate (2014) Summary page 10. - K012380: Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy, Stryker Leibinger (2001) Summary page 10. - K162341: Stryker OrthoMap Precision Knee system, Stryker Leibinger GmbH & Co KG (2016) Summary page 10. - (no number) OASYS Adjustable Drill Guide: named in the summary without a submission number - (no number) OASYS Drill Bits: named in the summary without a submission number - (no number) Xia CT Drill Bit: named in the summary without a submission number - (no number) Xia 4.5 Refresh Locking Knob: named in the summary without a submission number ## Most influential descendants - 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 - K241517: Q Guidance System; Mako Spine System; (2024), 2 descendants of its own ## Indications for use The Stryker Navigation System, when used with the SpineMap® 3D software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the pelvis or spine can be identified. The system assists in the positioning of instruments for procedures on the pelvis and spine, including: - Screw Placement in the spine, ilium, or pelvis The OrthoLock Anchoring System is intended to be used as an accessory to the Stryker Orthopedic, Trauma, and Spine Navigation Systems. It is a manual instrument intended to be used in surgery to anchor a patient tracker. The OrthoLock Anchoring System may be used as part of the Stryker Orthopedic, Trauma, and Spine Navigation Systems, which are indicated for any medical condition in which the use computer assisted surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The nGenius Spine Clamp is intended to be used as an accessory to the Stryker Spine Navigation System. The nGenius Spine Clamp is a manual instrument and intended to be used in spine surgery to attach a patient tracker to lumbar or thoracic spinous processes. The nGenius Spine Clamp may be used as part of the Stryker Spine Navigation, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The Navigated Drill Guide Set is intended to be used as an accessory to the Stryker Spine Navigation System. The Navigated Drill Guide Set consists of manual instruments that are intended to be used in spine surgery by providing guidance during drilling. The Navigated Drill Guide Set may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The Navigated Xia 3 Awl Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants. The Navigated Xia 3 Awl Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The Navigated Xia 3 Awl Taps are intended for use with the Rotational Navigation Adaptor and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 3, Xia 4.5, MANTIS, MANTIS Redux, and ES2 Spinal Fixation Systems using the Stryker Spine Navigation System. The Navigated Xia 3 Serrato Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants. The Navigated Xia 3 Serrato Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The Navigated Xia 3 Serrato Taps are intended for exclusive use with the Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 3 System - Serrato using the Stryker Spine Navigation System. Source page: https://510kreport.com/device/K172034 Methodology: https://510kreport.com/methodology