Cleared Traditional

Exactech? Equinoxe? Stemless Humeral Components

K192097 · Exactech, Inc. · Orthopedic

Apr 2020

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K192097 is an FDA 510(k) clearance for the Exactech? Equinoxe? Stemless Humeral Components, a Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (Class II — Special Controls, product code PKC), submitted by Exactech, Inc. (Gainsville, US). The FDA issued a Cleared decision on April 29, 2020, 268 days after receiving the submission on August 5, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K192097 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2019
Decision Date	April 29, 2020
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty