Cleared Traditional

iASSIST Knee System (K192080) - FDA 510(k) Clearance

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

K192080 · Orthosoft Inc. (d/b/a) Zimmer CAS · Orthopedic device
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Nov 2019
Decision
95d
Days
Class 2
Risk

K192080 is an FDA 510(k) clearance for the iASSIST Knee 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 Orthosoft Inc. (d/b/a) Zimmer CAS (Montreal, CA). The FDA issued a Cleared decision on November 5, 2019 after a review of 95 days - within the typical 510(k) review window.

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 Orthosoft Inc. (d/b/a) Zimmer CAS devices

Submission Details

510(k) Number K192080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2019
Decision Date November 05, 2019
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 344
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K192080.
Vital Navigation System
K191722 · Zimmer Biomet Spine, Inc. · Dec 2019
Navigated Anterolateral Disc Prep Instruments
K192336 · Medtronic Sofamor Danek USA, Inc. · Nov 2019
Brainlab Compatible K2M Navigation Instruments
K192911 · K2m, Inc. · Nov 2019
7D Surgical System
K192140 · 7D Surgical, Inc. · Nov 2019
Zimmer Biomet Universal Navigation System
K192133 · Zimmer Biomet Spine, Inc. · Oct 2019
ROSA ONE Spine application
K192173 · Medtech S.A · Oct 2019