Cleared Traditional

K162697 - Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal

K162697 is an FDA 510(k) clearance for Arthrex Glenoid Intelligent Reusable In..., manufactured by Custom Orthopaedic Solutions, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K162697 · Custom Orthopaedic Solutions, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
136d
Days
Class 2
Risk

K162697 is an FDA 510(k) clearance for the Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preo.... Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Custom Orthopaedic Solutions, Inc. (Cleveland, US). The FDA issued a Cleared decision on February 10, 2017 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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.

FDA 510(k) Submission Details - K162697

510(k) Number K162697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2016
Decision Date February 10, 2017
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 187
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K162697.
Medacta Anatomic Shoulder Prosthesis
K170910 · Medacta International S.A. · Aug 2017
Materialise Glenoid Positioning System
K170893 · Materialise NV · Jun 2017
BLUEPRINT Patient Specific Instrumentation
K162800 · Tornier S.A.S. · Feb 2017
BLUEPRINT Patient Specific Instrumentation
K161789 · Tornier S.A.S. · Dec 2016
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)
K161863 · Stryker GmbH · Nov 2016
AltiVate Anatomic Shoulder System
K162024 · Encore Medical, L.P. · Nov 2016