# 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

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Jul 25, 2024 after 90 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). 76 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 81 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). Cleared while this submission was under review Summary page 5.
- K112593: Styker Consolidated Operating Room Equipment (Core) System, Stryker Corporation (2012) Summary page 5.
- K211490: Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000, Stryker Corporation (2021) Summary page 5.
- K190172: Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments, Stryker (2019) Summary page 5.

## Most influential descendants
- K241517: Q Guidance System; Mako Spine System; (2024), 2 descendants of its own
- K252871: Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (2026), 1 descendant of its own
- 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
- K243958: Consolidated Operating Room Equipment (CORE) 2 Console (2025), 0 descendants of its own

## Indications for use
The Q Guidance System, when used with the Spine Guidance 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 any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative 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 procedures on the pelvis and spine, including: » Screw and Needle Placement in the spine or pelvis » Bone resection in the spine The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients. The CORE Q Footswitch is an accessory to the CORE 2 Console. When the pedal is actuated, it provides a signal to the console for variable speed control of the handpiece connected to the console. The footswitch is intended for use in surgical spine procedures. When used with the Stryker Spine Guidance Software, the footswitch when commanded by the console provides haptic feedback based upon user defined spatial boundaries. The Pi Drive 2 and Pi Drive 2 Plus Motors are intended for use with the Stryker® Consolidated Operating Room Equipment (CORE™) System. The motors, when used with a compatible Elite Q Attachment and a stereotactic instrument tracker, are also indicated as an accessory to the Stryker Spine Guidance Software. 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 laminotomy / laminectomy, minimally invasive surgery (MIS) spine, and orthopedic spine.

Source page: https://510kreport.com/device/K241171
Methodology: https://510kreport.com/methodology