Cleared Traditional

K242554 - Arthrex VAL and VAL KreuLock Compressio...

K242554 is the FDA 510(k) clearance for Arthrex VAL and VAL KreuLock Compressio... by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K242554 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
55d
Days
Class 2
Risk

K242554 is an FDA 510(k) clearance for the Arthrex VAL and VAL KreuLock™ Compression Screw System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on October 21, 2024 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K242554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2024
Decision Date October 21, 2024
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 904
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K242554.
Osteotomy Truss System (OTS)
K240388 · 4Web Medical, Inc. · Nov 2024
Bonebridge Osteosynthesis Plating System
K242399 · Bonebridge AG · Oct 2024
OIC Small / Mini Fragment Plate System
K242995 · The Orthopaedic Implant Company · Oct 2024
Clavicle and Scapula System
K240181 · Auxein Medical Pvt., Ltd. · Oct 2024
Pangea Platform
K242445 · Stryker GmbH · Oct 2024
BPS Wrist Fracture System
K242343 · Orthonovis, Inc. · Oct 2024