# K252871: Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Feb 6, 2026 after 149 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: 18 generations back to K853033 (1985). 80 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 82 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241517: Q Guidance System; Mako Spine System;, Stryker Leibinger GmbH & Co KG (2024) Summary page 6.
- 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.
- 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, Stryker Leibinger GmbH & Co KG (2024) Summary page 6.

## Most influential descendants
- K253623: Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor (2026), 0 descendants of its own

## Indications for use
Spine Guidance 5.3 Software Indications for Use: The Q Guidance System, when used with the Spine Guidance 5 Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients. The system is indicated for orthopedic and neurological spine procedures in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative stereotaxic guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified. The system assists in the positioning of instruments for surgical procedures on the spine and pelvis, including: - Screw and Needle Placement in the spine or pelvis - Bone resection in the spine - Interbody device placement in the lumbar spine (adults only) Q Interbody Instruments Indications for Use: VB Spine Q Interbody Instruments are intended to be used as accessories to the Stryker 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 Interbody Instruments are specifically designed for use with the Spine Guidance Software. They are intended to be used with associated trackers and adaptors to facilitate preparation and placement of VB Spine interbody implants in accordance with the indications and contraindications of the associated VB Spine Implant System and/or Stryker Spine Guidance System. Elite Q Attachments and Cutting Accessories: The Elite Q Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE™) 2 Console and the Pi Drive 2 Motor or the Pi Drive 2 Plus Motor. The Elite Q Attachments, when used with a compatible motor and a stereotactic instrument tracker, are also indicated as an accessory to the Stryker Spine Guidance Software. Specific applications include but are not limited to minimally invasive spine (MIS) Spine applications, such as foraminotomy, facetectomy; orthopedic and neurological spine applications, such as corpectomy, pedicle subtraction osteotomy; and laminotomy / laminectomy.

Source page: https://510kreport.com/device/K252871
Methodology: https://510kreport.com/methodology