Cleared Traditional

Delta Xtend Reverse Shoulder System (K183077) - FDA 510(k) Clearance

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

K183077 · Depuy(Ireland) · Orthopedic device
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May 2019
Decision
193d
Days
Class 2
Risk

K183077 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) (Cork, IE). The FDA issued a Cleared decision on May 17, 2019 after a review of 193 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) devices

Submission Details

510(k) Number K183077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2018
Decision Date May 17, 2019
Days to Decision 193 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
71d slower than avg
Panel avg: 122d · This submission: 193d
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 Orthopajedics, Inc.
Yayoi Fujimaki

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 139
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K183077.
32mm Glenosphere and Humeral Cup
K192206 · Fx Shoulder USA, Inc. · Oct 2019
Delta Xtend Revers Shoulder System
K192448 · Depuy(Ireland) · Oct 2019
Exactech Equinoxe Humeral Augmented Trays
K191561 · Exactech, Inc. · Aug 2019
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
K183696 · Tornier, Inc. · Jan 2019
Glenoid Polyaxial Non-locking Screws
K181826 · Medacta International S.A. · Dec 2018
Integra TITAN Reverse Shoulder System
K181999 · Integra LifeSciences Corporation · Oct 2018