Cleared Traditional

K191561 - Exactech Equinoxe Humeral Augmented Trays (FDA 510(k) Clearance)

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

K191561 · Exactech, Inc. · Orthopedic device
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Aug 2019
Decision
68d
Days
Class 2
Risk

K191561 is an FDA 510(k) clearance for the Exactech Equinoxe Humeral Augmented Trays. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on August 20, 2019 after a review of 68 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 Exactech, Inc. devices

Submission Details

510(k) Number K191561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2019
Decision Date August 20, 2019
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 K191561.
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