Cleared Special

K050315 - DELTA HUMERAL CUPS

K050315 is an FDA 510(k) clearance for DELTA HUMERAL CUPS, 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 96-day FDA review.

K050315 · DePuy Orthopaedics, Inc. · Orthopedic device
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May 2005
Decision
96d
Days
Class 2
Risk

K050315 is an FDA 510(k) clearance for the DELTA HUMERAL CUPS. 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 May 16, 2005 after a review of 96 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. 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.

View all DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K050315

510(k) Number K050315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2005
Decision Date May 16, 2005
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
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 K050315.
ANATOMICAL SHOULDER INVERSE/REVERSE
K053274 · Zimmer GmbH · Jan 2006
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K052906 · Zimmer, Inc. · Dec 2005
ENCORE REVERSE SHOULDER PROSTHESIS
K051075 · Encore Medical, L.P. · May 2005
ENCORE REVERSE SHOULDER PROSTHESIS
K041066 · Encore Medical, L.P. · Mar 2005
AEQUALIS REVERSED SHOULDER PROSTHESIS
K050316 · Tornier · Mar 2005
AEQUALIS REVERSED SHOULDER PROSTHESIS
K041873 · Tornier · Aug 2004