# K083009: Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Feb 19, 2009 after 133 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: 2 generations back to K993239 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062640: Stryker Navigation System - Cranial Module, Model 6000-650-000, Stryker Instruments (2006) Summary page 2.
- K012380: Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy, Stryker Leibinger (2001) Summary page 2.

## Most influential descendants
- K093206: Orthomap 3D 1.1 Module (2010), 0 descendants of its own

## Indications for use
The Stryker Navigation System - OrthoMap® 3D Module 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 intra-operative guidance where a reference to a rigid anatomical structure can be identified. The system should be operated only by trained personnel such as surgeons and clinic staff. The Stryker Navigation System - OrthoMap® 3D Module supports, but is not limited to, the following surgical procedures: Orthopedic Oncology Procedures Surgical Planning Procedures * Segmentation to define volumes of interest using correlated, multi-modality image data, e.g. to assist outlining and visualizing bony structures such as aberrant pathology * Image based distance and angular measurement tools, e.g. to define and maintain safety margins to outlined bony structures * Image based resection plane planning to define resections relative to identified structures, e.g. to support limb salvage surgery taking safety margins into account * Virtual screw placement planning in the image data with variable screw length, head-length and diameter * Image based annotation point placement and visualization, e.g. to support repositioning of bony anatomic points during surgery Surgical Navigation Procedures * Intra-operative visualization of volume image data including visualization of pre-planned volumes of interest relative to the tracked instrument, supporting navigated excision of user-defined bony structures * Intra-operative visualization of resection planes relative to the tracked instrument on bony structures assisting bony resections * Intra-operative creation and visualization of annotation points, supporting recording of landmarks on bony anatomy, e.g. to assist oncology replacement prosthesis repositioning, leg length and rotation assessment or navigated implant placement * Navigated intra-operative screw placement based on pre-planned or intra-operative virtual screw definition

Source page: https://510kreport.com/device/K083009
Methodology: https://510kreport.com/methodology