# K232521: ExactechGPS® Total Ankle Application

- Pathway: 510(k) (Traditional)
- Applicant: Blue Ortho
- Decided: Nov 16, 2023 after 90 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: 14 generations back to K905070 (1991). 125 ancestors in all.
No later device cites it as a predicate yet.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213546: ExactechGPS Total Shoulder Application, Equinoxe Planning Software, Blue Ortho (2022) Summary page 4.

## Indications for use
The ExactechGPS is intended for use during preoperative planning and during orthopedic surgery to aid the surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient’s preoperative CT scan. The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application. The ExactechGPS Total Ankle Navigation Application is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating anatomical structures and aligning the tibial and talar components with the anatomical structures.

Source page: https://510kreport.com/device/K232521
Methodology: https://510kreport.com/methodology