# K241625: Anatase Navi Disposable Instrument

- Pathway: 510(k) (Special)
- Applicant: Remex Medical Corp.
- Decided: Jul 5, 2024 after 29 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: 6 generations back to K050438 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220348: Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V, Remex Medical Corporation (2022) Summary page 4.
- K180523: INTAI Surgery Navigation System, Intai Technology Corporation (2019) Summary page 4.
- K233513: Remex Spine Surgery Navigation System II, Remex Medical Corp. (2024) Summary page 4.

## Indications for use
The Anatase Navi Disposable Instrument is designed for use with Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II, are 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 : Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

Source page: https://510kreport.com/device/K241625
Methodology: https://510kreport.com/methodology