# K254157: CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: May 26, 2026 after 155 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: 16 generations back to K862807 (1986). 110 ancestors in all.
No later device cites it as a predicate yet.
3 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251282: StealthStation S8 Spine Software, Medtronic Navigation, Inc. (2025) Summary page 5.
- K241893: CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays, Medos International SARL (2024) Summary page 5.

## Indications for use
Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes implants as well as discectomy and / or bony resection, during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS SPINE Navigation as well as with the Brainlab Navigation System and the Medtronic StealthStation Navigation System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which: * the use of EXPEDIUM™ VIPER™ SYMPHONY™ OCT, TriALTIS™, and the CONDUIT™ Spine System is indicated, if used for implant placement, » the use of stereotactic surgery may be appropriate, and » reference to a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC™ POWEREASE System. The Navigation Enabled Instruments used in conjunction with the SYMPHONY ™ OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only. The Navigation Enabled Instruments indicated for discectomy and / or bony resection, as well as the CONDUIT implants placement are for use with Medtronic StealthStation System only.

Source page: https://510kreport.com/device/K254157
Methodology: https://510kreport.com/methodology