Cleared Traditional

K182516 - Comprehensive Nano Stemless Shoulder

K182516 is the FDA 510(k) clearance for Comprehensive Nano Stemless Shoulder by Biomet Manufacturing Corp. It is a Class 2 Orthopedic device (product code PKC) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K182516 · Biomet Manufacturing Corp · Orthopedic device
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Apr 2019
Decision
221d
Days
Class 2
Risk

K182516 is an FDA 510(k) clearance for the Comprehensive Nano 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 Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on April 22, 2019 after a review of 221 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 Biomet Manufacturing Corp devices

Submission Details

510(k) Number K182516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2018
Decision Date April 22, 2019
Days to Decision 221 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
99d slower than avg
Panel avg: 122d · This submission: 221d
Pathway characteristics
Predicate-based equivalence.

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. 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
NCT01936259 Completed Interventional Industry-sponsored

Comprehensive Shoulder System Nano IDE

A Study of the Comprehensive Shoulder System With Nano Humeral Component in Total Shoulder Arthroplasty

258
Patients (actual)
12
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Joint Disease
Study design Parallel
Eligibility All sexes · 21 Years+
Sponsor Zimmer Biomet (industry)
Started 2013-08-01 → Primary completion 2018-11-21 → Completed 2019-09-27
Primary outcome
American Shoulder and Elbow Surgeon's Score (ASES)
Secondary outcome
American Shoulder and Elbow Surgeon's Score (ASES)
View full study on ClinicalTrials.gov

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 K182516.
Arthrex Eclipse Shoulder Prosthesis System
K201542 · Arthrex, Inc. · Jul 2020
AltiVate Anatomic Canal-Sparing (CS) Shoulder
K193226 · Encore Medical, L.P. · Jun 2020
Exactech® Equinoxe® Stemless Humeral Components
K192097 · Exactech, Inc. · Apr 2020
Exactech Equinoxe Stemless Shoulder
K173388 · Exactech, Inc. · Mar 2018
Sidus Stem-Free Shoulder
K171858 · Zimmer GmbH · Dec 2017
Simpliciti Shoulder System
K143552 · Tornier, Inc. · Mar 2015