Spine Guidance 5.4 Software +9 more— 510(k) K253623

Name: FDA 510(k) clearance K253623
Creator: U.S. Food and Drug Administration
Published: 2026-02-19

Substantially Equivalent

Stryker Leibinger GmbH & Co KG

FDA 510(k) clearance K253623 for Spine Guidance 5.4 Software +9 more, Substantially Equivalent on 2026-02-19. Applicant: Stryker Leibinger GmbH & Co KG. Device class: 2.

Summary

Stryker Leibinger lists ten items: five Spine Guidance 5.4 entries (Software, Upgrade, Update, Software Enable, and Sales Demo), plus Q Drill Tracker, NavLock Adapter, Elite Q Attacments (spelled that way in the record), Elite Cutting Accessories, and Maestro Air Motor. They're filed under product code OLO, orthopedic stereotaxic instrument. The record doesn't describe the items beyond their names.

Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.

Stryker Leibinger filed from Freiburg Im Breisgau, Germany. The decision came 93 calendar days after FDA received it (November 18, 2025 to February 19, 2026), and it was substantially equivalent.

Clearance details

Device name as filed: 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
Applicant: Stryker Leibinger GmbH & Co KG
Product code: Product code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-11-18
Decision date: 2026-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg Im Breisgau, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLO

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K262567 — GPS Ankle2026-10-26
K260403 — 7D Surgical System (10-0001)2026-10-19
K263234 — TMINI Miniature Robotic System2026-10-16
K263154 — CarboClear® Cervical Navigated Instruments2026-10-09
K262257 — Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine2026-09-30

More clearances from Stryker Leibinger GmbH & Co KG

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K261054 — RibPlate System2026-07-01
K254233 — MEDPOR Customized Implant Kit2026-03-12
K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories2026-02-06
K243491 — SternalPlate Expansion2024-12-11
K241517 — Q Guidance System; Mako Spine System2024-08-27

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.