Cleared Special

K201542 - Arthrex Eclipse Shoulder Prosthesis System

K201542 is an FDA 510(k) clearance for Arthrex Eclipse Shoulder Prosthesis System, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code PKC cleared through the Special 510(k) pathway after a 29-day FDA review.

K201542 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
29d
Days
Class 2
Risk

K201542 is an FDA 510(k) clearance for the Arthrex Eclipse Shoulder Prosthesis 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 Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 8, 2020 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K201542

510(k) Number K201542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2020
Decision Date July 08, 2020
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

PKC Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (PKC) and FDA review panel - the closest regulatory comparables to K201542.
Ignite Stemless Anatomic Shoulder System
K203108 · Ignite Orthopedics, LLC · Jul 2021
Easytech® Anatomical Shoulder System
K201391 · Fx Shoulder USA, Inc. · Feb 2021
Arthrex Eclipse Titanium Humeral Head
K203100 · Arthrex, Inc. · Nov 2020
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
K201542 · Arthrex Eclipse Shoulder Prosthesis System
Download PDF FDA Summary Arthrex, Inc.