Cleared Traditional

K020562 - APEX INTRAMEDULLARY NAIL SYSTEM

K020562 is an FDA 510(k) clearance for APEX INTRAMEDULLARY NAIL SYSTEM, manufactured by Magly Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K020562 · Magly Orthopedics, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
85d
Days
Class 2
Risk

K020562 is an FDA 510(k) clearance for the APEX INTRAMEDULLARY NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Magly Orthopedics, LLC (Woodinville, US). The FDA issued a Cleared decision on May 16, 2002 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 - K020562

510(k) Number K020562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2002
Decision Date May 16, 2002
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 446
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K020562.
T2 FEMORAL NAIL
K021744 · Howmedica Osteonics Corp. · Jun 2002
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
K021008 · Advanced Orthopaedic Solutions, Inc. · Jun 2002
G4 SLEEVED NAIL
K020962 · Biomet Manufacturing, Inc. · May 2002
T2 ARTHRODESIS NAIL SYSTEM
K020384 · Howmedica Osteonics Corp. · May 2002
S2 FEMORAL NAIL
K021026 · Howmedica Osteonics Corp. · Apr 2002
S2 TIBIAL NAIL
K021027 · Howmedica Osteonics Corp. · Apr 2002