Cleared Traditional

K173388 - Exactech Equinoxe Stemless Shoulder

K173388 is the FDA 510(k) clearance for Exactech Equinoxe Stemless Shoulder by Exactech, Inc.. It is a Class 2 Orthopedic device (product code PKC) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K173388 · Exactech, Inc. · Orthopedic device
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Mar 2018
Decision
130d
Days
Class 2
Risk

K173388 is an FDA 510(k) clearance for the Exactech Equinoxe Stemless Shoulder. Classified as Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (product code PKC), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 9, 2018 after a review of 130 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Exactech, Inc. devices

Submission Details

510(k) Number K173388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2017
Decision Date March 09, 2018
Days to Decision 130 days
Submission Type Traditional
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
8d slower than avg
Panel avg: 122d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty
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 - PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

All 18
Devices cleared under the same product code (PKC) and FDA review panel - the closest regulatory comparables to K173388.
AltiVate Anatomic Canal-Sparing (CS) Shoulder
K193226 · Encore Medical, L.P. · Jun 2020
Exactech® Equinoxe® Stemless Humeral Components
K192097 · Exactech, Inc. · Apr 2020
Comprehensive Nano Stemless Shoulder
K182516 · Biomet Manufacturing Corp · Apr 2019
Sidus Stem-Free Shoulder
K171858 · Zimmer GmbH · Dec 2017
Simpliciti Shoulder System
K143552 · Tornier, Inc. · Mar 2015