Cleared Traditional

K203694 - DELTA XTEND Reverse Shoulder System

K203694 is the FDA 510(k) clearance for DELTA XTEND Reverse Shoulder System by Depuy Ireland UC. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K203694 · Depuy Ireland UC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2021
Decision
216d
Days
Class 2
Risk

K203694 is an FDA 510(k) clearance for the DELTA XTEND Reverse Shoulder System. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Depuy Ireland UC (Cork, IE). The FDA issued a Cleared decision on July 22, 2021 after a review of 216 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 Ireland UC devices

Submission Details

510(k) Number K203694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2020
Decision Date July 22, 2021
Days to Decision 216 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
94d slower than avg
Panel avg: 122d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHX Shoulder Prosthesis, Reverse Configuration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.
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 Consultant

DePuy Orthopaedics, Inc.
Jaclyn Cincotta

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.

Regulatory Peers - PHX Shoulder Prosthesis, Reverse Configuration

All 178
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K203694.
Inset Reverse Total Shoulder System
K210533 · Shoulder Innovations, Inc. · Aug 2021
Tecomet Global Unite Short Stem Instrumentation
K211553 · Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. · Aug 2021
Catalyst R1 Reverse Shoulder System
K211991 · Catalyst Orthoscience, Inc. · Jul 2021
Bone Screws dia. 5,0 mm
K210717 · Lima Corporate S.P.A. · Jul 2021
OVOMotion Reverse Shoulder Arthroplasty System
K203375 · Arthrosurface, Inc. · Jun 2021
Humeral Eccentric Reverse Metaphysis
K210207 · Medacta International S.A. · Mar 2021