Cleared Traditional

K163338 - OMNIBotics Knee System

K163338 is the FDA 510(k) clearance for OMNIBotics Knee System by Omnllife Science, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K163338 · Omnllife Science, Inc. · Orthopedic device
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Sep 2017
Decision
277d
Days
Class 2
Risk

K163338 is an FDA 510(k) clearance for the OMNIBotics Knee 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 Omnllife Science, Inc. (Raynham, US). The FDA issued a Cleared decision on September 1, 2017 after a review of 277 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 Omnllife Science, Inc. devices

Submission Details

510(k) Number K163338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2016
Decision Date September 01, 2017
Days to Decision 277 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
155d slower than avg
Panel avg: 122d · This submission: 277d
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 355
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K163338.
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
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977 · Smith & Nephew, Inc. · May 2017
Smith & Nephew SURESHOT Distal Targeting System V4.0
K170280 · Smith & Nephew, Inc. · Apr 2017