# K173372: ExactechGPS Total Shoulder Application

- Pathway: 510(k) (Special)
- Applicant: Blue Ortho
- Decided: Nov 24, 2017 after 28 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: 10 generations back to K911686 (1991). 58 ancestors in all.
14 later devices descend from it; 3 cite 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)
- K162567: ExactechGPS Total Shoulder Application, Equinoxe Planning Software, Blue Ortho (2017) Summary page 5.

## Most influential descendants
- 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
- K232280: NextAR™ TSA Platform (2023), 1 descendant of its own

## Recalls of this device
- Jun 5, 2023 · Class II · Z-2050-2023: The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

## 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/K173372
Methodology: https://510kreport.com/methodology