Cleared Traditional

K021579 - MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM

K021579 is an FDA 510(k) clearance for MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM, manufactured by Magly Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K021579 · Magly Orthopedics, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
87d
Days
Class 2
Risk

K021579 is an FDA 510(k) clearance for the MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Magly Orthopedics, LLC (Woodinville, US). The FDA issued a Cleared decision on August 9, 2002 after a review of 87 days - a notably fast clearance 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: 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 Magly Orthopedics, LLC devices

FDA 510(k) Submission Details - K021579

510(k) Number K021579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2002
Decision Date August 09, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
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 883
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K021579.
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K022726 · Pioneer Surgical Technology · Sep 2002
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K021556 · Synthes (Usa) · Aug 2002
LACTOSORB MINI INTERFERENCE SCREW
K021254 · Biomet Orthopedics, Inc. · Jul 2002
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K021280 · Inion , Ltd. · Jul 2002
SMALL HAMMER TOE PIN
K021828 · Biomet, Inc. · Jul 2002