# K240951: Invictus Robotic Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine
- Decided: Jun 6, 2024 after 59 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: 32 generations back to K841189 (1984). 1,261 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 1,264 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232044: Invictus Robotic Navigation Instruments, Alphatec Spine, Inc. (2023) Summary page 4.
- K232275: Invictus® Spinal Fixation System, Alphatec Spine, Inc. (2023) Summary page 4.
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 4.

## Most influential descendants
- 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 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/K240951
Methodology: https://510kreport.com/methodology