Cleared Traditional

K153215 - SmartBase for Arthrex Glenoid IRIS

K153215 is an FDA 510(k) clearance for SmartBase for Arthrex Glenoid IRIS, 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 106-day FDA review.

K153215 · Custom Orthopaedic Solutions, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
106d
Days
Class 2
Risk

K153215 is an FDA 510(k) clearance for the SmartBase for Arthrex Glenoid IRIS. 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 19, 2016 after a review of 106 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 - K153215

510(k) Number K153215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2015
Decision Date February 19, 2016
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
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 K153215.
Materialise Glenoid Positioning System
K153602 · Materialise NV · Apr 2016
SMR 3-Pegs Glenoids
K153722 · Lima Corporate S.P.A. · Apr 2016
Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
K160085 · Zimmer GmbH · Mar 2016
Arthrex Univers Apex, Size 5 Stem
K153115 · Arthrex, Inc. · Nov 2015
Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
K151293 · Tornier S.A.S. · Sep 2015
SMR Modular Glenoid
K143256 · Lima Corporate S.P.A. · May 2015