Cleared Traditional

Comprehensive Nano Stemless Shoulder

K182516 · Biomet Manufacturing Corp · Orthopedic

Apr 2019

Decision

221d

Days

Class 2

Risk

About This 510(k) Submission

K182516 is an FDA 510(k) clearance for the Comprehensive Nano Stemless Shoulder, a Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (Class II — Special Controls, product code PKC), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on April 22, 2019, 221 days after receiving the submission on September 13, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K182516 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty