# K180523: INTAI Surgery Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Intai Technology Corporation
- Decided: Sep 20, 2019 after 570 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: 2 generations back to K050438 (2005). 2 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133444: Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System, Medtronic Navigation, Inc. (2014) Summary page 4.

## Most influential descendants
- K220348: Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V (2022), 6 descendants of its own
- K230783: Anatase Spine Surgery Navigation System (2023), 5 descendants of its own
- K233513: Remex Spine Surgery Navigation System II (2024), 4 descendants of its own
- K251315: Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II (2025), 1 descendant of its own
- K262506: Remex Spine Surgery Navigation - Universal Instruments (2026), 0 descendants of its own

## Indications for use
The INTAI Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient’s fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include but are not limited to: Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

Source page: https://510kreport.com/device/K180523
Methodology: https://510kreport.com/methodology