# K262506: Remex Spine Surgery Navigation - Universal Instruments

- Pathway: 510(k) (Special)
- Applicant: Remex Medical Corp.
- Decided: Aug 20, 2026 after 30 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: 7 generations back to K050438 (2005). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251315: Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II, Remex Medical Corp. (2025) Summary page 4.

## Indications for use
The Remex Spine Surgery Navigation – Universal Instruments is intended for use with the Remex Spine Surgery Navigation System II (K251315). The subject device functions as an accessory to the navigation system to support instrument tracking during spine surgical procedures. The Remex Spine Surgery Navigation System II is indicated for precise positioning of surgical instruments or spinal implants during general spine 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. The system is used to conduct procedures such as Posterior-approach spinal implant procedures, such as pedicle screw placement, with the lumbar region.

Source page: https://510kreport.com/device/K262506
Methodology: https://510kreport.com/methodology