Cleared Special

K180632 - Exactech Equinoxe Small Reverse Shoulde...

K180632 is the FDA 510(k) clearance for Exactech Equinoxe Small Reverse Shoulde... by Exactech, Inc.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Special 510(k) pathway after a 135-day FDA review.

K180632 · Exactech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
135d
Days
Class 2
Risk

K180632 is an FDA 510(k) clearance for the Exactech Equinoxe Small Reverse Shoulder System. 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 July 25, 2018 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exactech, Inc. devices

Submission Details

510(k) Number K180632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2018
Decision Date July 25, 2018
Days to Decision 135 days
Submission Type Special
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
13d slower than avg
Panel avg: 122d · This submission: 135d
Pathway characteristics
Modification to existing cleared device.

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 K180632.
Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap
K182536 · Exactech, Inc. · Oct 2018
Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
K182039 · Arthrex, Inc. · Sep 2018
Comprehensive Reverse Shoulder System
K181611 · Biomet Manufacturing Corp · Sep 2018
Integra TITAN Reverse Shoulder System
K173717 · Integra LifeSciences Corporation · Jun 2018
Arthrex Univers Revers Modular Glenoid System
K173900 · Arthrex, Inc. · Apr 2018
Medacta Shoulder System Short Humeral Diaphysis
K180089 · Medacta International S.A. · Apr 2018