Cleared Traditional

Easytech® Anatomical Shoulder System (K201391) - FDA 510(k) Clearance

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

K201391 · Fx Shoulder USA, Inc. · Orthopedic device
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Feb 2021
Decision
265d
Days
Class 2
Risk

K201391 is an FDA 510(k) clearance for the Easytech® Anatomical Shoulder System. 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 Fx Shoulder USA, Inc. (Dallas, US). The FDA issued a Cleared decision on February 16, 2021 after a review of 265 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 Fx Shoulder USA, Inc. devices

Submission Details

510(k) Number K201391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2020
Decision Date February 16, 2021
Days to Decision 265 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
143d slower than avg
Panel avg: 122d · This submission: 265d
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 16
Devices cleared under the same product code (PKC) and FDA review panel - the closest regulatory comparables to K201391.
Shoulder Innovations Total Shoulder System
K213615 · Shoulder Innovations, Inc. · Mar 2022
GLOBAL ICON Stemless Shoulder System
K212683 · Depuy(Ireland) · Jan 2022
Ignite Stemless Anatomic Shoulder System
K203108 · Ignite Orthopedics, LLC · Jul 2021
Arthrex Eclipse Titanium Humeral Head
K203100 · Arthrex, Inc. · Nov 2020
Arthrex Eclipse Shoulder Prosthesis System
K201542 · Arthrex, Inc. · Jul 2020
AltiVate Anatomic Canal-Sparing (CS) Shoulder
K193226 · Encore Medical, L.P. · Jun 2020