# K162567: ExactechGPS Total Shoulder Application, Equinoxe Planning Software

- Pathway: 510(k) (Traditional)
- Applicant: Blue Ortho
- Decided: Apr 5, 2017 after 203 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: 9 generations back to K911686 (1991). 57 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 73 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 5.
- K063408: Ctlogics Navigations Systems, Praxim Medivision, SA (2007) Summary page 5.
- K151568: Arthrex OrthoVis Preoperative Plan, Custom Orthopaedic Solutions, Inc. (2015) Summary page 5.

## Most influential descendants
- 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
- K250108: OptiVu™ Shoulder (2025), 1 descendant of its own

## Recalls of this device
- Jul 11, 2017 · Class II · Z-0603-2018: Vix Bit may fracture during use.

## Indications for use
The ExactechGPS is intended for use during preoperative planning and during stereotaxic 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 Shoulder Application is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.

Source page: https://510kreport.com/device/K162567
Methodology: https://510kreport.com/methodology