# K213877: ExactechGPS® System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Ortho
- Decided: May 2, 2022 after 140 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: 7 generations back to K002053 (2000). 11 ancestors in all.
1 later device descends 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)
- K193618: ExactechGPS System, Blue Ortho (2020) Summary page 4.

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

## Indications for use
The ExactechGPS® System 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/K213877
Methodology: https://510kreport.com/methodology