Cleared Traditional

K203230 - Global Shoulder and Delta CTA systems (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203230 · Depuy Lnc. · Orthopedic device
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Apr 2021
Decision
151d
Days
Class 2
Risk

K203230 is an FDA 510(k) clearance for the Global Shoulder and Delta CTA systems. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Depuy Lnc. (Warsaw, US). The FDA issued a Cleared decision on April 2, 2021 after a review of 151 days - an extended review cycle.

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 Lnc. devices

Submission Details

510(k) Number K203230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2020
Decision Date April 02, 2021
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 189
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K203230.
AETOS Shoulder System - CONCELOC Glenoids
K254084 · Smith & Nephew, Inc. · Apr 2026
Catalyst F1x Shoulder System
K252418 · Catalyst Orthoscience, Inc. · Nov 2025
AETOS Shoulder System Meta Humeral Prosthesis Size 0
K252416 · Smith & Nephew, Inc. · Oct 2025
MyShoulder Planner (5.3SSWPL)
K241292 · Medacta International S.A. · Jan 2025
Tornier Humeral Reconstruction System (Tornier HRS)
K241878 · Stryker Corporation (Tornier, Inc.) · Dec 2024
Tornier Humeral Reconstruction System (Tornier HRS)
K241609 · Stryker Corporation (Tornier, Inc.) · Sep 2024