Cleared Special

K122442 - DEPUY CTA REVERSE SHOULDER SYSTEM

K122442 is an FDA 510(k) clearance for DEPUY CTA REVERSE SHOULDER SYSTEM, manufactured by Depuy France. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 27-day FDA review.

K122442 · Depuy France · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
27d
Days
Class 2
Risk

K122442 is an FDA 510(k) clearance for the DEPUY CTA REVERSE SHOULDER SYSTEM. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Depuy France (Warsaw, US). The FDA issued a Cleared decision on September 6, 2012 after a review of 27 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K122442

510(k) Number K122442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2012
Decision Date September 06, 2012
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 205
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K122442.
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K130661 · Zimmer, Inc. · May 2013
EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE
K121067 · Exactech, Inc. · Dec 2012
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS
K122692 · Zimmer, Inc. · Dec 2012
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
K121183 · Biomet Corporation · Jul 2012
ARROW REVERSE SHOULDER SYSTEM
K112193 · Fournitures Hospitalieres Industrie · Jul 2012
SEVIIN REVERSE SHOULDER
K120374 · Ingen Orthopedics, LLC · Jul 2012
K122442 · DEPUY CTA REVERSE SHOULDER SYSTEM
Download PDF FDA Summary Depuy France