Cleared Traditional

K260624 - Arthrex Radial Head Replacement System

K260624 is the FDA 510(k) clearance for Arthrex Radial Head Replacement System by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code KWI) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K260624 · Arthrex, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2026
Decision
154d
Days
Class 2
Risk

K260624 is an FDA 510(k) clearance for the Arthrex Radial Head Replacement System. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 30, 2026 after a review of 154 days - an extended review cycle.

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 Arthrex, Inc. devices

Submission Details

510(k) Number K260624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2026
Decision Date July 30, 2026
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K260624.
BioPoly Radial Head Implant
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DePuy Synthes Radial Head Replacement System
K213563 · DePuy Synthes · Mar 2022
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