Cleared Traditional

K243195 - Arthrex SS VAL and VAL KreuLock Compres...

K243195 is the FDA 510(k) clearance for Arthrex SS VAL and VAL KreuLock Compres... by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K243195 · Arthrex, Inc. · Orthopedic device
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Jan 2025
Decision
101d
Days
Class 2
Risk

K243195 is an FDA 510(k) clearance for the Arthrex SS VAL and VAL KreuLock™ Compression Screw 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 January 10, 2025 after a review of 101 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

Submission Details

510(k) Number K243195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2024
Decision Date January 10, 2025
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K243195.
TITANEX Screw Systems
K250304 · Vilex, LLC · Mar 2025
Caliber Intramedullary Fixation System
K242896 · Nvision Biomedical Technologies · Feb 2025
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
K242442 · Innovate Orthopaedics, Ltd. · Jan 2025
Locking Screw,CoCrMo
K242348 · Double Medical Technology, Inc. · Dec 2024
OsteoCoil™ Nitinol Compression System (Multiple Component PNs)
K233567 · Flower Orthopedics Corporation Dba Conventus Flower Ortho · Nov 2024
Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
K240175 · Tigon Medical · Oct 2024