Cleared Special

K051075 - ENCORE REVERSE SHOULDER PROSTHESIS

K051075 is an FDA 510(k) clearance for ENCORE REVERSE SHOULDER PROSTHESIS, manufactured by Encore Medical, L.P.. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 30-day FDA review.

K051075 · Encore Medical, L.P. · Orthopedic device
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May 2005
Decision
30d
Days
Class 2
Risk

K051075 is an FDA 510(k) clearance for the ENCORE REVERSE SHOULDER PROSTHESIS. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on May 27, 2005 after a review of 30 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 Encore Medical, L.P. devices

FDA 510(k) Submission Details - K051075

510(k) Number K051075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2005
Decision Date May 27, 2005
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K051075.
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM
K060704 · Zimmer, Inc. · May 2006
ANATOMICAL SHOULDER INVERSE/REVERSE
K053274 · Zimmer GmbH · Jan 2006
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K052906 · Zimmer, Inc. · Dec 2005
DELTA HUMERAL CUPS
K050315 · DePuy Orthopaedics, Inc. · May 2005
ENCORE REVERSE SHOULDER PROSTHESIS
K041066 · Encore Medical, L.P. · Mar 2005
AEQUALIS REVERSED SHOULDER PROSTHESIS
K050316 · Tornier · Mar 2005