# K171556: K2M Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: K2m
- Decided: Jan 16, 2018 after 231 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
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K181890: Brainlab Compatible K2M Navigation Instruments (2018), 11 descendants of its own
- K192911: Brainlab Compatible K2M Navigation Instruments (2019), 9 descendants of its own
- K203205: Navigated Spine Instruments (2021), 8 descendants of its own
- K240662: Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece (2024), 7 descendants of its own
- K241171: Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (2024), 4 descendants of its own

Source page: https://510kreport.com/device/K171556
Methodology: https://510kreport.com/methodology