Cleared Traditional

K212683 - GLOBAL ICON Stemless Shoulder System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence.

K212683 · Depuy(Ireland) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2022
Decision
148d
Days
Class 2
Risk

K212683 is an FDA 510(k) clearance for the GLOBAL ICON Stemless Shoulder System. Classified as Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (product code PKC), Class II - Special Controls.

Submitted by Depuy(Ireland) (Cork, IE). The FDA issued a Cleared decision on January 19, 2022 after a review of 148 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 Depuy(Ireland) devices

Submission Details

510(k) Number K212683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2021
Decision Date January 19, 2022
Days to Decision 148 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 122d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

DePuy Orthopaedics, Inc.
Megan Bernier

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03168672 Terminated Interventional Industry-sponsored

GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow Up Study

171
Patients (actual)
12
Sites
Treatment
Purpose
Open label
Masking
Condition studied Osteoarthritis; Post Traumatic Arthritis
Study design Single group
Eligibility All sexes · 21 Years+
Sponsor DePuy Orthopaedics (industry)
Started 2017-10-18 → Primary completion 2021-12-13 → Completed 2024-06-18
Primary outcome
Percentage of Participants With Overall Composite Clinical Success
Secondary outcome
Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative
View full study on ClinicalTrials.gov

Regulatory Peers - PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

All 18
Devices cleared under the same product code (PKC) and FDA review panel - the closest regulatory comparables to K212683.
FX V135 EASYTECH® Shoulder System
K254154 · FX Shoulder Solutions, Inc. · May 2026
AETOS Shoulder System Stemless Humeral Prosthesis
K252129 · Smith & Nephew, Inc. · Oct 2025
INHANCE INTACT™
K243248 · Depuy Ireland UC · Dec 2024
OsseoFit Stemless Shoulder System
K241873 · Zimmer, Inc. · Dec 2024
AETOS Shoulder System Stemless Humeral Prosthesis
K240716 · Smith & Nephew, Inc. · Nov 2024
SMR Stemless Anatomic
K221758 · Lima Corporate S.P.A. · Mar 2023