Cleared Traditional

K193515 - Mako Total Knee Application

K193515 is the FDA 510(k) clearance for Mako Total Knee Application by Mako Surgical Corp.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K193515 · Mako Surgical Corp. · Orthopedic device
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Jul 2020
Decision
208d
Days
Class 2
Risk

K193515 is an FDA 510(k) clearance for the 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 July 14, 2020 after a review of 208 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 Mako Surgical Corp. devices

Submission Details

510(k) Number K193515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2019
Decision Date July 14, 2020
Days to Decision 208 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
86d slower than avg
Panel avg: 122d · This submission: 208d
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 K193515.
CarboClear Navigated Instruments
K201251 · CarboFix Orthopedics , Ltd. · Aug 2020
Navigation Enabled Intruments
K200791 · Medos International SARL · Jul 2020
Joimax Intracs System
K192663 · Joimax GmbH · Jul 2020
ExcelsiusGPS Cranial 1.0 Module
K200047 · Globus Medical, Inc. · Jul 2020
OMNIBotics Knee System
K200888 · Corin, Ltd. · Jun 2020
Streamline Navigated Instruments
K200095 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Jun 2020