Cleared Traditional

K162697 - Arthrex Glenoid Intelligent Reusable In...

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
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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.

View all Custom Orthopaedic Solutions, Inc. devices

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 166
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