Cleared Special

K173717 - Integra TITAN Reverse Shoulder System

K173717 is an FDA 510(k) clearance for Integra TITAN Reverse Shoulder System, manufactured by Integra LifeSciences Corporation. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 198-day FDA review.

K173717 · Integra LifeSciences Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
198d
Days
Class 2
Risk

K173717 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 June 21, 2018 after a review of 198 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K173717

510(k) Number K173717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2017
Decision Date June 21, 2018
Days to Decision 198 days
Submission Type Special
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
76d slower than avg
Panel avg: 122d · This submission: 198d
Pathway characteristics
Modification to existing cleared device.

PHX Device Classification - Class 2, Special Controls

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 206
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K173717.
Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
K182039 · Arthrex, Inc. · Sep 2018
Comprehensive Reverse Shoulder System
K181611 · Biomet Manufacturing Corp · Sep 2018
Exactech Equinoxe Small Reverse Shoulder System
K180632 · Exactech, Inc. · Jul 2018
Arthrex Univers Revers Modular Glenoid System
K173900 · Arthrex, Inc. · Apr 2018
Medacta Shoulder System Short Humeral Diaphysis
K180089 · Medacta International S.A. · Apr 2018
Arthrex UNIVERS REVERS COATED BASEPLATE
K172371 · Arthrex, Inc. · Mar 2018
K173717 · Integra TITAN Reverse Shoulder System
Download PDF FDA Summary Integra LifeSciences …