# K201006: K2M Navigation Instruments

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Aug 7, 2020 after 112 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: 23 generations back to K853033 (1985). 500 ancestors in all.
No later device cites it as a predicate yet.
1 of 501 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171321: K2M Navigation Instruments, K2m (2017) Summary page 4.
- K181890: Brainlab Compatible K2M Navigation Instruments, K2m (2018) Summary page 4.
- K183381: Navigation Enabled Instruments, Stryker (2019) Summary page 4.

## Indications for use
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (Denali, Mesa, Everest, and Yukon) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Navigated Screw Inserters are also compatible with the Medtronic [IPC POWEREASE System. The K2M Navigation Instruments are not intended for navigation of occipital screws.

Source page: https://510kreport.com/device/K201006
Methodology: https://510kreport.com/methodology