Cleared Traditional

Arthrex Eclipse Shoulder Prosthesis System (K183194) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence.

K183194 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
249d
Days
Class 2
Risk

K183194 is an FDA 510(k) clearance for the Arthrex Eclipse Shoulder Prosthesis System. Classified as Total Shoulder Arthroplasty System (product code QHQ), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 26, 2019 after a review of 249 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 Arthrex, Inc. devices

Submission Details

510(k) Number K183194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date July 26, 2019
Days to Decision 249 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
127d slower than avg
Panel avg: 122d · This submission: 249d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QHQ Total Shoulder Arthroplasty System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition To Treat Pain And Lack Of Function In The Shoulder.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01790113 Terminated Interventional Industry-sponsored

Arthrex Eclipse™ Shoulder Prosthesis

A Prospective, Randomized, Multicenter Study Comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder Prothesis to the Univers™ II Shoulder Prosthesis in Patients With a Degenerative Joint Disease

303
Patients (actual)
16
Sites
Treatment
Purpose
Open label
Masking
Condition studied Osteoarthritis
Study design Parallel
Eligibility All sexes · 21 Years+
Principal investigator Melissa Hirschberg
Sponsor Arthrex, Inc. (industry)
Started 2013-02-04 → Primary completion 2019-06-07
Primary outcome
Composite Clinical Success
View full study on ClinicalTrials.gov