# K193618: ExactechGPS System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Ortho
- Decided: Sep 2, 2020 after 251 days
- Product code: OLO (Orthopedic 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: 6 generations back to K002053 (2000). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152764: Exactech GPS, Blue Ortho (2016) Summary page 4.

## Most influential descendants
- K213877: ExactechGPS® System (2022), 1 descendant of its own
- K233299: ExactechGPS® System (2024), 0 descendants of its own

## Recalls of this device
- Sep 10, 2020 · Class II · Z-0288-2021: Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational document

## 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. TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

Source page: https://510kreport.com/device/K193618
Methodology: https://510kreport.com/methodology