Cleared Traditional

K233912 - ARIX Cannulated Screw System

K233912 is an FDA 510(k) clearance for ARIX Cannulated Screw System, manufactured by Jeil Medical Corporation. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K233912 · Jeil Medical Corporation · Orthopedic device
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Mar 2024
Decision
90d
Days
Class 2
Risk

K233912 is an FDA 510(k) clearance for the ARIX Cannulated Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on March 11, 2024 after a review of 90 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 Jeil Medical Corporation devices

FDA 510(k) Submission Details - K233912

510(k) Number K233912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2023
Decision Date March 11, 2024
Days to Decision 90 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 faster than avg
Panel avg: 122d · This submission: 90d
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 924
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K233912.
Arthrex Cannulated Screw System
K240815 · Arthrex, Inc. · Jun 2024
Cannulated Headless Bone Screws
K233008 · Aap Implantate AG · Jun 2024
DynaNail Mini Tapered Hybrid
K240530 · MedShape, Inc. · Mar 2024
OSSIOfiber® Threaded Trimmable Fixation Nails
K233198 · OSSIO , Ltd. · Mar 2024
SnapHammer Hammertoe Correction System
K231453 · Nvision Biomedical Technologies, Inc. · Feb 2024
TDM Screw System
K231860 · Tdm Co., Ltd. · Jan 2024