# K200791: Navigation Enabled Intruments

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jul 31, 2020 after 127 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: 12 generations back to K862807 (1986). 65 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K173338: Navigated INFINITY™ Instruments, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 4.

## Most influential descendants
- K231527: TriALTIS Navigation Enabled Instruments (2023), 3 descendants of its own
- K233255: CROSSNAV Navigation Enabled Instruments (2024), 2 descendants of its own
- K241893: CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (2024), 1 descendant of its own
- K254157: CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (2026), 0 descendants of its own
- K233256: Robotic Integration Instruments (2024), 0 descendants of its own

## Indications for use
Navigation Enabled Instruments are reusable instruments intended 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 intended; and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which: • the use of EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® 2, VIPER® SAI, EXPEDIUM VERSE®, VIPER PRIME® (without stylet control) or SYMPHONYTM OCT system is indicated, • 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 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 Synthes Small Battery Drive II System 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.

Source page: https://510kreport.com/device/K200791
Methodology: https://510kreport.com/methodology