Cleared Traditional

DePuy Synthes Radial Head Replacement System

K213563 · DePuy Synthes · Orthopedic
Mar 2022
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K213563 is an FDA 510(k) clearance for the DePuy Synthes Radial Head Replacement System, a Prosthesis, Elbow, Hemi-, Radial, Polymer (Class II — Special Controls, product code KWI), submitted by DePuy Synthes (19380, US). The FDA issued a Cleared decision on March 18, 2022, 129 days after receiving the submission on November 9, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3170.

Submission Details

510(k) Number K213563 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2021
Decision Date March 18, 2022
Days to Decision 129 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3170