Cleared Special

K150458 - Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere

K150458 is an FDA 510(k) clearance for Exactech Equinoxe Reverse Shoulder 46x2..., manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code PHX cleared through the Special 510(k) pathway after a 80-day FDA review.

K150458 · Exactech, Inc. · Orthopedic device
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May 2015
Decision
80d
Days
Class 2
Risk

K150458 is an FDA 510(k) clearance for the Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere. 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 May 14, 2015 after a review of 80 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. 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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K150458

510(k) Number K150458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2015
Decision Date May 14, 2015
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

PHX Device Classification - Class 2, Special Controls

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 202
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K150458.
Aequalis Fx2
K152966 · Tornier S.A.S. · Jan 2016
Humelock II Reversible Shoulder System
K150488 · Fx Solutions · Nov 2015
ARROW Humeral stems size 6 and 16
K150568 · Fournitures Hospitalieres Industrie · Oct 2015
ARROW Reverse Shoulder long keel and short keel glenoid base
K142778 · Fournitures Hospitalieres Industrie · Mar 2015
Univers Rivers Shoulder Prosthesis System
K142863 · Arthrex, Inc. · Nov 2014
AEQUALIS FX2
K141345 · Tornier S.A.S. · Nov 2014