Cleared Traditional

K191561 - Exactech Equinoxe Humeral Augmented Trays

K191561 is the FDA 510(k) clearance for Exactech Equinoxe Humeral Augmented Trays by Exactech, Inc.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K191561 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 180
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K191561.
SMR TT Augmented Glenoid System
K191746 · Lima Corporate S.P.A. · Nov 2019
32mm Glenosphere and Humeral Cup
K192206 · Fx Shoulder USA, Inc. · Oct 2019
Delta Xtend Revers Shoulder System
K192448 · Depuy(Ireland) · Oct 2019
Delta Xtend Reverse Shoulder System
K183077 · Depuy(Ireland) · May 2019
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
K183696 · Tornier, Inc. · Jan 2019
Glenoid Polyaxial Non-locking Screws
K181826 · Medacta International S.A. · Dec 2018