Cleared Traditional

K213563 - DePuy Synthes Radial Head Replacement S...

K213563 is an FDA 510(k) clearance for DePuy Synthes Radial Head Replacement S..., manufactured by DePuy Synthes. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 129-day FDA review.

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

K213563 is an FDA 510(k) clearance for the DePuy Synthes Radial Head Replacement System. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by DePuy Synthes (West Chester, US). The FDA issued a Cleared decision on March 18, 2022 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3170 - 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 DePuy Synthes devices

FDA 510(k) Submission Details - K213563

510(k) Number K213563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 122d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWI Device Classification - Class 2, Special Controls

Product Code KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3170
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 - KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

All 20
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K213563.
Arthrex Radial Head Replacement System
K260624 · Arthrex, Inc. · Jul 2026
BioPoly Radial Head Implant
K233592 · BioPoly, LLC · Mar 2024
ALIGN Radial Head System
K231188 · Skeletal Dynamics, Inc. · Sep 2023
Avenger Radial Head System
K212872 · In2bones USA, LLC · Dec 2021
Avenger Radial Head System
K192754 · In2bones USA, LLC · Jan 2020
Revolution Radial Head
K183618 · Ignite Orthopedics, Inc. · May 2019