# K171321: K2M Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: K2m
- Decided: Aug 30, 2017 after 118 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K853033 (1985). 421 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 423 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143375: CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K143628: Navigated Vertex Select Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K070229: Range Spinal System, K2m, Inc. (2007) Summary page 4.
- K153031: RANGE/DENALI/MESA Spinal System, K2m, Incorporated (2015) Summary page 4.
- K103440: Everest Spinal System, K2m, Inc. (2011) Summary page 4.
- K161369: EVEREST Spinal System, K2m, Incorporated (2016) Summary page 4.

## Most influential descendants
- K201006: K2M Navigation Instruments (2020), 0 descendants of its own

## Recalls of this device
- Dec 2, 2016 · Class II · Z-0052-2020: Instruments were developed without adequate consideration given to the need for a new regulatory filing. This event was reported to FDA as part of Stryker's retrospective review of K2M product field a

## Indications for use
K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALI, MESA, EVEREST) 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. The K2M Navigation 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy

Source page: https://510kreport.com/device/K171321
Methodology: https://510kreport.com/methodology