Cleared Traditional

K203230 - Global Shoulder and Delta CTA systems

K203230 is an FDA 510(k) clearance for Global Shoulder and Delta CTA systems, manufactured by Depuy Lnc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 151-day FDA review.

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

FDA 510(k) Submission Details - K203230

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.

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 158
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K203230.
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ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
K202289 · Stryker GmbH · Dec 2020
Alliance Augmented Glenoid
K193180 · Zimmer, Inc. · Feb 2020