# K152764: Exactech GPS

- Pathway: 510(k) (Traditional)
- Applicant: Blue Ortho
- Decided: Jul 13, 2016 after 293 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002053 (2000). 9 ancestors in all.
19 later devices descend from it; 2 cite 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)
- K100742: Exactech GPS, Blue Ortho (2010) Summary page 4.

## Most influential descendants
- 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
- K233199: ROSA® Shoulder System (2024), 3 descendants of its own

## Recalls of this device
- Sep 22, 2019 · Class II · Z-1149-2020: The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).

## Indications for use
The EXACTECH GPS 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 primary and revision Total Knee Arthroplasty.

Source page: https://510kreport.com/device/K152764
Methodology: https://510kreport.com/methodology