Cleared Traditional

K192097 - Exactech® Equinoxe® Stemless Humeral Components (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192097 · Exactech, Inc. · Orthopedic device
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Apr 2020
Decision
268d
Days
Class 2
Risk

K192097 is an FDA 510(k) clearance for the Exactech® Equinoxe® Stemless Humeral Components. 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. (Gainsville, US). The FDA issued a Cleared decision on April 29, 2020 after a review of 268 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. 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 K192097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 122d · This submission: 268d
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 K192097.
FX V135 EASYTECH® Shoulder System
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AETOS Shoulder System Stemless Humeral Prosthesis
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INHANCE INTACT™
K243248 · Depuy Ireland UC · Dec 2024
OsseoFit Stemless Shoulder System
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AETOS Shoulder System Stemless Humeral Prosthesis
K240716 · Smith & Nephew, Inc. · Nov 2024
SMR Stemless Anatomic
K221758 · Lima Corporate S.P.A. · Mar 2023