Cleared Special

K171780 - OrthAlign Plus System

K171780 is an FDA 510(k) clearance for OrthAlign Plus System, manufactured by Orthalign, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Special 510(k) pathway after a 26-day FDA review.

K171780 · Orthalign, Inc. · Orthopedic device
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Jul 2017
Decision
26d
Days
Class 2
Risk

K171780 is an FDA 510(k) clearance for the OrthAlign Plus 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 Orthalign, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on July 11, 2017 after a review of 26 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 Orthalign, Inc. devices

FDA 510(k) Submission Details - K171780

510(k) Number K171780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2017
Decision Date July 11, 2017
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
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 371
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K171780.
Mako Total Knee Application
K172219 · Mako Surgical Corp. · Sep 2017
VIPER PRIME navigated inserter
K170937 · Medos International SARL · Sep 2017
EXCELSIUS GPS
K171651 · Globus Medical, Inc. · Aug 2017
Mako Partial Knee Application
K170891 · Mako Surgical Corp. · May 2017
Mako Total Knee Application
K170581 · Mako Surgical Corp. · May 2017
Mako Partial Knee Application
K170584 · Mako Surgical Corp. · May 2017