# K213546: ExactechGPS Total Shoulder Application, Equinoxe Planning Software

- Pathway: 510(k) (Traditional)
- Applicant: Blue Ortho
- Decided: Jan 6, 2022 after 59 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: 13 generations back to K905070 (1991). 124 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173372: ExactechGPS Total Shoulder Application, Blue Ortho (2017) Summary page 4.
- K203315: BLUEPRINT™ Patient Specific Instrumentation, Tornier S.A.S. (2021) Summary page 4.

## Most influential descendants
- K233199: ROSA® Shoulder System (2024), 3 descendants of its own
- K250108: OptiVu™ Shoulder (2025), 1 descendant of its own
- K230904: Arthrex Virtual Implant Positioning (VIP) System (2023), 1 descendant of its own
- K260582: ROSA® Shoulder System (2026), 0 descendants of its own
- K252841: Real Intelligence™ Cori™ XT (Cori XT) (2025), 0 descendants 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 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 Shoulder Planning Application is specifically indicated for pre-operative planning of Total Shoulder Arthroplasty using the Equinoxe system. The ExactechGPS Total Shoulder Planning Application permits to visualize, measure and reconstruct anatomical structures in order to select and place the glenoid and humeral components. The ExactechGPS Total Shoulder Navigation 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/K213546
Methodology: https://510kreport.com/methodology