Cleared Special

K162325 - Exactech Equinoxe Reverse Shoulder Lock...

K162325 is the FDA 510(k) clearance for Exactech Equinoxe Reverse Shoulder Lock... by Exactech, Inc.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Special 510(k) pathway after a 199-day FDA review.

K162325 · Exactech, Inc. · Orthopedic device
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Mar 2017
Decision
199d
Days
Class 2
Risk

K162325 is an FDA 510(k) clearance for the Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Sho.... 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 March 6, 2017 after a review of 199 days - an extended review cycle.

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 K162325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2016
Decision Date March 06, 2017
Days to Decision 199 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
77d slower than avg
Panel avg: 122d · This submission: 199d
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 K162325.
Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
K172767 · Zimmer, Inc. · Nov 2017
Medacta Shoulder System
K170452 · Medacta International S.A. · Oct 2017
ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System
K170711 · Zimmer GmbH · Jun 2017
SMR TT Metal Back Glenoid, Bone Graft instruments
K161120 · Lima Corporate S.P.A. · Feb 2017
Exactech® Equinoxe® Preserve Stem
K162726 · Exactech, Inc. · Feb 2017
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
K161742 · Tornier, Inc. · Nov 2016