# K260546: Q Pedicle Instruments

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Mar 17, 2026 after 27 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: 16 generations back to K853033 (1985). 69 ancestors in all.
No later device cites it as a predicate yet.
1 of 70 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Stryker Leibinger GmbH & Co KG (2024) Summary page 6.

## Indications for use
VB Spine Q Pedicle Instruments are intended to be used as accessories to Stryker's Spine Guidance System to facilitate placement of VB Spine implants. They can be navigated instruments or non-navigated manual instruments. When navigated, VB Spine Q Pedicle Instruments are specifically designed for use with the Spine Guidance Software. They are intended to be used with a Q Navigation Adaptor and associated trackers manually or under power with a Stryker Rotary Handpiece to facilitate pedicle preparation and placement of VB Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients in accordance with the indications and contraindications of the associated VB Spine Implant System and/or Stryker's Spine Guidance System.

Source page: https://510kreport.com/device/K260546
Methodology: https://510kreport.com/methodology