Cleared Special

K062116 - DELTA CTA REVERSE SHOULDER SYSTEM HUMER...

K062116 is an FDA 510(k) clearance for DELTA CTA REVERSE SHOULDER SYSTEM HUMER..., manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 24-day FDA review.

K062116 · DePuy Orthopaedics, Inc. · Orthopedic device
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Aug 2006
Decision
24d
Days
Class 2
Risk

K062116 is an FDA 510(k) clearance for the DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 18, 2006 after a review of 24 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.

View all DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K062116

510(k) Number K062116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2006
Decision Date August 18, 2006
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 183
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K062116.
DELTA XTEND REVERSE SHOULDER MODULAR STEM
K071379 · DePuy Orthopaedics, Inc. · Sep 2007
EQUINOXE REVERSE SHOULDER SYSTEM
K063569 · Exactech, Inc. · Feb 2007
DELTA XTEND REVERSE SHOULDER SYSTEM
K062250 · DePuy Orthopaedics, Inc. · Feb 2007
AEQUALIS REVERSED PROSTHESIS
K061439 · Tornier · Jul 2006
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM
K060704 · Zimmer, Inc. · May 2006
ANATOMICAL SHOULDER INVERSE/REVERSE
K053274 · Zimmer GmbH · Jan 2006