Cleared Traditional

K190556 - Zimmer Biomet Universal Navigation System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190556 · Zimmer Biomet Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
233d
Days
Class 2
Risk

K190556 is an FDA 510(k) clearance for the Zimmer Biomet Universal Navigation 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 Zimmer Biomet Spine, Inc. (Westminister, US). The FDA issued a Cleared decision on October 24, 2019 after a review of 233 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer Biomet Spine, Inc. devices

Submission Details

510(k) Number K190556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2019
Decision Date October 24, 2019
Days to Decision 233 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 122d · This submission: 233d
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 422
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K190556.
Foundation Surgical Navigated Lateral Disc Prep Instruments
K260011 · Foundation Surgical Group, Inc. · Apr 2026
SPINEART Navigation Instrument System
K254158 · Spineart SA · Apr 2026
SYMPHONY Navigation Ready Instruments
K260240 · Medos International SARL · Mar 2026
REAL INTELLIGENCE™ CORI™
K260601 · Blue Belt Technologies, Inc. · Mar 2026
CUVIS-joint (CJ150)
K252037 · Curexo, Inc. · Mar 2026
TiLink-L Navigation Instruments
K253604 · SurGenTec, LLC · Mar 2026