# 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

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Feb 19, 2026 after 93 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: 19 generations back to K853033 (1985). 82 ancestors in all.
No later device cites it as a predicate yet.
1 of 83 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252871: Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories, Stryker Leibinger GmbH & Co KG (2026). Cleared while this submission was under review Summary page 6.
- K150801: Stryker Maestro Air Motors, Stryker Corporation (2015) Summary page 6.

## 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) 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. The Stryker Consolidated Operating Room Equipment (CORE™) Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries. The Maestro Air Motor, when used with a compatible Elite Q Attachment and a stereotactic instrument tracker, is also indicated as an accessory to the Stryker Spine Guidance Software.

Source page: https://510kreport.com/device/K253623
Methodology: https://510kreport.com/methodology