# K232044: Invictus Robotic Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Oct 6, 2023 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: 31 generations back to K841189 (1984). 1,236 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 1,240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220862: E-GPS Navigated Instruments, Precision Spine, Inc. (2022) Summary page 4.
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 4.
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System, Alphatec Spine, Inc. (2022) Summary page 4.

## Most influential descendants
- K240951: Invictus Robotic Navigation Instruments (2024), 2 descendants of its own
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own

## Indications for use
The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System modular screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

Source page: https://510kreport.com/device/K232044
Methodology: https://510kreport.com/methodology