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ExactechGPS Total Shoulder Application, Equinoxe Planning Software

by Blue Ortho 510(k) 2 variants

Active United States Open recall

510(k) K213546

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213546 Date6 Jan 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2050-2023 FDA Class II initiated 5 Jun 2023

    The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

Specification

510(k)

510(k) Number
FDA Product Code
OLO
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ExactechGPS Total Shoulder Application, Equinoxe Planning Software is a computer-assisted navigation system for preoperative planning and intraoperative guidance in total shoulder arthroplasty. It integrates patient-specific CT scan data with hardware tracking to create virtual bone models and align Equinoxe shoulder implants. The system facilitates precise anatomical landmark identification and endoprosthesis positioning during surgery, enhancing procedural accuracy.

This software is used in orthopedic surgical settings for preoperative planning and intraoperative navigation, requiring preoperative CT scans and intraoperative hardware trackers. Supplied as a digital application, it is intended for single-use per surgical case and does not require sterilization. The device is FDA-cleared under 510(k) number K213546, with no specific MRI safety or sterility classifications noted. No additional regulatory markings beyond the 510(k) clearance are provided.

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