# K100742: Exactech GPS

- Pathway: 510(k) (Traditional)
- Applicant: Blue Ortho
- Decided: Oct 21, 2010 after 219 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 K002053 (2000). 8 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022579: Stryker Navigation System-Knee Module, Stryker Leibinger (2003) Summary page 1.
- K060282: Total Knee Surgetics Navigation System, Praxim S.A (2006) Summary page 1.

## Most influential descendants
- K152764: Exactech GPS (2016), 19 descendants of its own
- K162567: ExactechGPS Total Shoulder Application, Equinoxe Planning Software (2017), 15 descendants of its own
- K173372: ExactechGPS Total Shoulder Application (2017), 14 descendants of its own
- K213546: ExactechGPS Total Shoulder Application, Equinoxe Planning Software (2022), 8 descendants of its own
- K210153: NextAR RSA Platform (2021), 5 descendants of its own

## Indications for use
The BLUE NAVIGATION SYSTEM is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for Total Knee Arthroplasty.

Source page: https://510kreport.com/device/K100742
Methodology: https://510kreport.com/methodology