# K093206: Orthomap 3D 1.1 Module

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Aug 4, 2010 after 295 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 K983831 (1999). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083009: Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000, Stryker Leibinger GmbH & Co KG (2009) Summary page 2.
- K062640: Stryker Navigation System - Cranial Module, Model 6000-650-000, Stryker Instruments (2006) Summary page 2.
- K042512: Vectorvision Acl, Brainlab AG (2005) Summary page 2.
- K050651: Medtronic Orthopaedic Trauma Application, Medtronic Navigation, Inc. (2005) Summary page 2.

## Indications for use
The Stryker Navigation System - OrthoMapo 3D 1.1 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 intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system offers the following features and functions: * Import of multi-modality image data * Surgical planning, such as image manipulation and visualization and procedural planning * Surgical navigation, such as manual and automatic registration and precise. positioning of instruments and implants The system should be operated only by trained personnel such as surgeons and clinic staff. The system can assist surgeons in the following, but not limited to, orthopedic surgical procedures: * Orthopedic oncology procedures * Cam type FAI (femoroacetabular impingement) surgery * AOL (anterior cruciate ligament) reconstruction

Source page: https://510kreport.com/device/K093206
Methodology: https://510kreport.com/methodology