# K182104: NavLock Trackers, Robotic Reference Frame

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation
- Decided: Nov 2, 2018 after 91 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: 10 generations back to K862807 (1986). 62 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171267: NavLock Trackers, Medtronic Navigation (2017) Summary page 6.

## Most influential descendants
- K201327: NavLock Trackers (2020), 2 descendants of its own
- K252989: “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set (2026), 0 descendants of its own
- K232800: Navigation Tracking Instruments (2024), 0 descendants of its own

## Recalls of this device
- Aug 28, 2019 · Class II · Z-1693-2020: Product was incorrectly assembled which could affect navigation accuracy of the device.

## Indications for use
The NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the MAZOR X Stealth™ Edition system. The NavLock™ Trackers should only be used with Medtronic instruments on the MAZOR X Stealth™ Edition system. The Robotic Reference Frame is an accessory to the MAZOR X Stealth Edition system and is intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth Edition system

Source page: https://510kreport.com/device/K182104
Methodology: https://510kreport.com/methodology