Cleared Traditional

K162375 - Envision 3D: Image Guidance System

K162375 is an FDA 510(k) clearance for Envision 3D: Image Guidance System, manufactured by 7D Surgical, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K162375 · 7D Surgical, Inc. · Orthopedic device
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Dec 2016
Decision
127d
Days
Class 2
Risk

K162375 is an FDA 510(k) clearance for the Envision 3D: Image Guidance 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 7D Surgical, Inc. (Toronto, CA). The FDA issued a Cleared decision on December 29, 2016 after a review of 127 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 7D Surgical, Inc. devices

FDA 510(k) Submission Details - K162375

510(k) Number K162375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2016
Decision Date December 29, 2016
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 433
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K162375.
KneeAlign 2 System
K163379 · Orthalign, Inc. · Mar 2017
Stryker OrthoMap Versatile Hip System
K162937 · Stryker Corporation · Feb 2017
OrthAlign Plus System
K162962 · Orthalign, Inc. · Jan 2017
Stryker OrthoMap Precision Knee system
K162341 · Stryker Leibinger GmbH & Co KG · Oct 2016
TSolution One Cup1 Surgical System
K162195 · THINK Surgical, Inc. · Sep 2016
Precision Screw
K160385 · Cryptych Pty, Ltd. · Jul 2016