Cleared Traditional

K254215 - Arthrex Beaming System

K254215 is an FDA 510(k) clearance for Arthrex Beaming System, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K254215 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
130d
Days
Class 2
Risk

K254215 is an FDA 510(k) clearance for the Arthrex Beaming System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on May 8, 2026 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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

FDA 510(k) Submission Details - K254215

510(k) Number K254215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date May 08, 2026
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K254215.
VEOFIX Snap Off Screw
K253108 · Steps Ortho · Jun 2026
CoLink® & CoLag® Non-Sterile Screws
K261154 · In2bones USA, LLC · May 2026
TriMed Compression Screws
K261241 · TriMed, Inc. · May 2026
OSSIOfiber® Threaded Trimmable Fixation Nail
K254077 · OSSIO , Ltd. · May 2026
TITAN Nail
K260934 · Medartis AG · Apr 2026
CoAptix S System
K252699 · University of Utah, Department of Orthopaedics · Apr 2026