# K241893: CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Sep 16, 2024 after 80 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: 15 generations back to K862807 (1986). 107 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233255: CROSSNAV Navigation Enabled Instruments, DePuy Synthes (2024) Summary page 6.
- K201661: Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set, Medos International SARL (2020) Summary page 6.
- K221618: Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System, Brainlab AG (2022) Summary page 6.
- K233254: TELIGEN System Navigation Ready Instruments, DePuy Synthes (2024) Summary page 6.

## Most influential descendants
- K254157: CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (2026), 0 descendants of its own

## Indications for use
Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws 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 System 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 EXPEDIUMTm, VIPERm, SYMPHONYm OCT and the TriALTISTM Spine System is indicated, * 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 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 Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which: * the use of stereotactic surgery may be appropriate, and * reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays. These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instruments, when used with UNAS, can be: * pre-calibrated with the VELYS Spine System using VELYS Spine Instrument Arrays, * pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer. Via the CROSSNAV Adaptor, the UNAS Navigation Arrays are also compatible with DePuy Synthes Navigation Enabled Instruments indicated for use with the Brainlab Navigation System.

Source page: https://510kreport.com/device/K241893
Methodology: https://510kreport.com/methodology