Cleared Traditional

K030941 - AEQUALIS REVERSED SHOULDER PROSTHESIS (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030941 · Tornier · Orthopedic device
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May 2004
Decision
416d
Days
Class 2
Risk

K030941 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 (Midvale, US). The FDA issued a Cleared decision on May 14, 2004 after a review of 416 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Tornier devices

Submission Details

510(k) Number K030941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2003
Decision Date May 14, 2004
Days to Decision 416 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
294d slower than avg
Panel avg: 122d · This submission: 416d
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 199
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K030941.
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
K252404 · Biomet Orthopedics · Apr 2026
Equinoxe® Shoulder System
K260583 · Exactech, Inc. · Apr 2026
InSet Reverse Total Shoulder System
K254128 · Shoulder Innovations, Inc. · Apr 2026
Blueprint Patient-Specific Instrumentation
K253674 · Stryker Corporation (Tornier, S.A.S.) · Apr 2026
INHANCE™ Reverse Shoulder System
K253624 · Depuy Ireland UC · Mar 2026
MSS - Monobloc stem
K250644 · Medacta International S.A. · Feb 2026