Cleared Traditional

K213614 - Cannulated Screws

K213614 is an FDA 510(k) clearance for Cannulated Screws, manufactured by Maxxion Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K213614 · Maxxion Medical, LLC · Orthopedic device
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Aug 2022
Decision
261d
Days
Class 2
Risk

K213614 is an FDA 510(k) clearance for the Cannulated Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Maxxion Medical, LLC (Miami, US). The FDA issued a Cleared decision on August 3, 2022 after a review of 261 days - an extended review cycle.

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 Maxxion Medical, LLC devices

FDA 510(k) Submission Details - K213614

510(k) Number K213614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2021
Decision Date August 03, 2022
Days to Decision 261 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
139d slower than avg
Panel avg: 122d · This submission: 261d
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 690
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K213614.
Tandry Compression Screw System
K220359 · Microware Precision Co., Ltd. · Sep 2022
Arthrex Compression FT Pins
K220839 · Arthrex, Inc. · Sep 2022
CAPTIVATE® Compression Screws
K222409 · Globus Medical, Inc. · Sep 2022
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
K220319 · Stryker GmbH · Jun 2022
Hand Trauma Screw System
K220723 · Skeletal Dynamics, Inc. · May 2022
ExsoMed INnate NanoTM Lag Screw System
K220892 · Exsomed Corp. · Apr 2022