# K233299: ExactechGPS® System

- Pathway: 510(k) (Traditional)
- Applicant: Blue Ortho
- Decided: Jan 26, 2024 after 119 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: 8 generations back to K002053 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213877: ExactechGPS® System, Blue Ortho (2022) Summary page 4.

## 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/K233299
Methodology: https://510kreport.com/methodology