Cleared Traditional

K041873 - AEQUALIS REVERSED SHOULDER PROSTHESIS

K041873 is the FDA 510(k) clearance for AEQUALIS REVERSED SHOULDER PROSTHESIS by Tornier. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K041873 · Tornier · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2004
Decision
44d
Days
Class 2
Risk

K041873 is an FDA 510(k) clearance for the AEQUALIS REVERSED SHOULDER PROSTHESIS. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Tornier (Montbonnot, FR). The FDA issued a Cleared decision on August 25, 2004 after a review of 44 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tornier devices

Submission Details

510(k) Number K041873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2004
Decision Date August 25, 2004
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
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 K041873.
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
AEQUALIS REVERSED SHOULDER PROSTHESIS
K030941 · Tornier · May 2004
DELTA SHOULDER
K021478 · Depuy, Inc. · Nov 2003