Cleared Traditional

K161189 - Integra TITAN Reverse Shoulder System

K161189 is the FDA 510(k) clearance for Integra TITAN Reverse Shoulder System by Integra LifeSciences Corporation. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K161189 · Integra LifeSciences Corporation · Orthopedic device
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Aug 2016
Decision
120d
Days
Class 2
Risk

K161189 is an FDA 510(k) clearance for the Integra TITAN Reverse Shoulder System. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Austin, US). The FDA issued a Cleared decision on August 25, 2016 after a review of 120 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 Integra LifeSciences Corporation devices

Submission Details

510(k) Number K161189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2016
Decision Date August 25, 2016
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
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 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 K161189.
SMR TT Metal Back Glenoid, Bone Graft instruments
K161120 · Lima Corporate S.P.A. · Feb 2017
Exactech® Equinoxe® Preserve Stem
K162726 · Exactech, Inc. · Feb 2017
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
K161742 · Tornier, Inc. · Nov 2016
COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
K152754 · Biomet Manufacturing Corp · May 2016
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
K150458 · Exactech, Inc. · May 2015
Univers Rivers Shoulder Prosthesis System
K142863 · Arthrex, Inc. · Nov 2014