Cleared Special

K170584 - Mako Partial Knee Application

K170584 is an FDA 510(k) clearance for Mako Partial Knee Application, manufactured by Mako Surgical Corp.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Special 510(k) pathway after a 72-day FDA review.

K170584 · Mako Surgical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
72d
Days
Class 2
Risk

K170584 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 May 11, 2017 after a review of 72 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. 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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K170584

510(k) Number K170584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2017
Decision Date May 11, 2017
Days to Decision 72 days
Submission Type Special
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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

OLO Device Classification - Class 2, Special Controls

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 433
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K170584.
NavLock Trackers
K171267 · Medtronic Navigation · Jul 2017
Mako Partial Knee Application
K170891 · Mako Surgical Corp. · May 2017
Mako Total Knee Application
K170581 · Mako Surgical Corp. · May 2017
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977 · Smith & Nephew, Inc. · May 2017
NAVIO
K170360 · Blue Belt Technologies, Inc. · May 2017
StealthStation S8 Spine Software v1.0.0
K170011 · Medtronic Navigation · May 2017