Cleared Traditional

K041066 - ENCORE REVERSE SHOULDER PROSTHESIS

K041066 is the FDA 510(k) clearance for ENCORE REVERSE SHOULDER PROSTHESIS by Encore Medical, L.P.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K041066 · Encore Medical, L.P. · Orthopedic device
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Mar 2005
Decision
335d
Days
Class 2
Risk

K041066 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 March 24, 2005 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Encore Medical, L.P. devices

Submission Details

510(k) Number K041066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2004
Decision Date March 24, 2005
Days to Decision 335 days
Submission Type Traditional
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
213d slower than avg
Panel avg: 122d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 178
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K041066.
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K052906 · Zimmer, Inc. · Dec 2005
ENCORE REVERSE SHOULDER PROSTHESIS
K051075 · Encore Medical, L.P. · May 2005
DELTA HUMERAL CUPS
K050315 · DePuy Orthopaedics, Inc. · May 2005
AEQUALIS REVERSED SHOULDER PROSTHESIS
K050316 · Tornier · Mar 2005
AEQUALIS REVERSED SHOULDER PROSTHESIS
K041873 · Tornier · Aug 2004
AEQUALIS REVERSED SHOULDER PROSTHESIS
K030941 · Tornier · May 2004