Cleared Traditional

K191998 - Mako Total Hip Application

K191998 is the FDA 510(k) clearance for Mako Total Hip Application by Mako Surgical Corp.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K191998 · Mako Surgical Corp. · Orthopedic device
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Sep 2019
Decision
60d
Days
Class 2
Risk

K191998 is an FDA 510(k) clearance for the Mako Total Hip Application, Mako Total Knee Application. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Mako Surgical Corp. (Fort Lauderdale, US). The FDA issued a Cleared decision on September 24, 2019 after a review of 60 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 Mako Surgical Corp. devices

Submission Details

510(k) Number K191998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2019
Decision Date September 24, 2019
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K191998.
Premia Spine XL Instruments
K191854 · Premia Spine, Ltd. · Oct 2019
Intellijoint® Navigation System
K191507 · Intellijoint Surgical, Inc. · Oct 2019
Precision Spine Navigation Instrumentation
K181606 · Precision Spine, Inc. · Sep 2019
INTAI Surgery Navigation System
K180523 · Intai Technology Corporation · Sep 2019
Spine & Trauma Navigation
K183605 · Brainlab AG · Aug 2019
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
K191039 · Medtronic Sofamor Danek USA, Inc. · Aug 2019