Cleared Traditional

K220593 - Spine Guidance Software

K220593 is the FDA 510(k) clearance for Spine Guidance Software by Stryker Leibinger GmbH & Co KG. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K220593 · Stryker Leibinger GmbH & Co KG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
87d
Days
Class 2
Risk

K220593 is an FDA 510(k) clearance for the Spine Guidance Software, Stryker Q Guidance System. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on May 27, 2022 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Leibinger GmbH & Co KG devices

Submission Details

510(k) Number K220593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2022
Decision Date May 27, 2022
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 364
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K220593.
Knee 3
K220652 · Brainlab AG · Jun 2022
CoreLink Navigation Instruments
K220973 · Corelink, LLC · Jun 2022
VisAR
K220146 · Novarad Corporation · May 2022
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments
K221180 · Medtronic Sofamor Danek USA, Inc. · May 2022
7D Surgical System - Percutaneous Application (7D Flash Frame)
K220522 · 7D Surgical · May 2022
Universal Pilot Guidance Instrument System
K213491 · Ctl Medical Corporation · May 2022