Cleared Traditional

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

K253623 · Stryker Leibinger GmbH & Co KG · Orthopedic

Feb 2026

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K253623 is an FDA 510(k) clearance for the 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, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Stryker Leibinger GmbH & Co KG (Freiburg Im Breisgau, DE). The FDA issued a Cleared decision on February 19, 2026, 93 days after receiving the submission on November 18, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K253623 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 2025
Decision Date	February 19, 2026
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.