# K240721: ExcelsiusFlex™

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jun 14, 2024 after 88 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: 21 generations back to K040583 (2004). 764 ancestors in all.
No later device cites it as a predicate yet.
5 of 765 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 4.
- K193515: Mako Total Knee Application, Mako Surgical Corp. (2020) Summary page 4.
- K202769: VELYS™ Robotic-Assisted Solution, Depuy Ireland UC (2021) Summary page 4.
- K211616: ExcelsiusHub, Globus Medical, Inc. (2021) Summary page 4.
- K182000: AQrate Robotic Assistance System, Globus Medical, Inc. (2019) Summary page 4.

## Indications for use
ExcelsiusFlex™ when used in conjunction with ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of a tool holder to be used by surgeons for navigating and/or guiding compatible surgical instruments provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or directly acquired anatomical structures. The system is indicated to assist the surgeon in planning the position of the implant components and preparing the bony anatomy during orthopedic procedures. The Total Knee Arthroplasty (TKA) implant systems compatible with ExcelsiusFlex™ are GENflex2® and ACTIFY™ Total Knee System. The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans, fluoroscopy or directly acquired anatomical structures. The system is indicated for the planning of orthopedic devices and placement of spinal and orthopedic bone screws and interbody fusion devices.

Source page: https://510kreport.com/device/K240721
Methodology: https://510kreport.com/methodology