# K162937: Stryker OrthoMap Versatile Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Feb 23, 2017 after 126 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: 1 generation back to K022365 (2003). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022365: Stryker Navigation System - Hip Module, Stryker Instruments (2003) Summary page 4.

## Most influential descendants
- K171525: Intellijoint HIP Generation 2B System (2017), 3 descendants of its own
- K213380: 360CAS (2022), 2 descendants of its own
- K191507: Intellijoint® Navigation System (2019), 2 descendants of its own
- K223767: Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System (2023), 1 descendant of its own
- K223927: 360CAS (2023), 1 descendant of its own

## Indications for use
The Stryker OrthoMap Versatile Hip system, which is comprised of the OrthoMap Versatile Hip 2.0 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 such as but not limited to the pelvis, or femur, can be identified. The system is indicated for conditions of the hip joint in which the use of image guided surgery may be appropriate. The Stryker OrthoMap Versatile Hip system is indicated for the following surgical procedures: • Any form of Total Hip Athroplasty (THA), e.g. open or minimally-invasive • Precisely position instruments, implants and bony tissue during orthopedic hip surgery • Revisions

Source page: https://510kreport.com/device/K162937
Methodology: https://510kreport.com/methodology