Cleared Special

K172301 - Mako Partial Knee Application

K172301 is the FDA 510(k) clearance for Mako Partial Knee Application by Mako Surgical Corp.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Special 510(k) pathway after a 94-day FDA review.

K172301 · Mako Surgical Corp. · Orthopedic device
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Nov 2017
Decision
94d
Days
Class 2
Risk

K172301 is an FDA 510(k) clearance for the Mako Partial 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 November 2, 2017 after a review of 94 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mako Surgical Corp. devices

Submission Details

510(k) Number K172301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2017
Decision Date November 02, 2017
Days to Decision 94 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Modification to existing cleared device.

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 355
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K172301.
K2M Navigation Instruments
K171556 · K2m · Jan 2018
Spineology Navigation Instruments
K172518 · Spineology, Inc. · Jan 2018
NuVasive Navigation Instruments
K172623 · Nu Vasive, Incorporated · Dec 2017
Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap
K172034 · Stryker Corporation · Oct 2017
VIPER PRIME navigated inserter
K170937 · Medos International SARL · Sep 2017
EXCELSIUS GPS
K171651 · Globus Medical, Inc. · Aug 2017