Cleared Traditional

K162962 - OrthAlign Plus System

K162962 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 Traditional 510(k) pathway after a 91-day FDA review.

K162962 · Orthalign, Inc. · Orthopedic device
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Jan 2017
Decision
91d
Days
Class 2
Risk

K162962 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 January 23, 2017 after a review of 91 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. 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 Orthalign, Inc. devices

FDA 510(k) Submission Details - K162962

510(k) Number K162962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2016
Decision Date January 23, 2017
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K162962.
Navigated Instrument System
K162921 · Orthofix, Inc. · Mar 2017
TSolution One Surgical System Model 210
K170430 · THINK Surgical, Inc. · Mar 2017
Stryker OrthoMap Versatile Hip System
K162937 · Stryker Corporation · Feb 2017
TSolution One Cup1 Surgical System
K162195 · THINK Surgical, Inc. · Sep 2016
Alphatec Navigation Instruments
K153603 · Alphatec Spine, Inc. · Apr 2016
TSolution One w/ACG+ Surgical System
K153647 · THINK Surgical, Inc. · Feb 2016