Cleared Traditional

Equinoxe? Shoulder System

K243448 · Exactech, Inc. · Orthopedic

Aug 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K243448 is an FDA 510(k) clearance for the Equinoxe? Shoulder System, a Shoulder Prosthesis, Reverse Configuration (Class II — Special Controls, product code PHX), submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on August 1, 2025, 267 days after receiving the submission on November 7, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K243448 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2024
Decision Date	August 01, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PHX — Shoulder Prosthesis, Reverse Configuration
Device Class	Class II — 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.