Cleared Traditional

Atlas™ Humeral Nail System (K241484) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241484 · Orthopedic Designs North America, Inc. (Odi-Na) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
165d
Days
Class 2
Risk

K241484 is an FDA 510(k) clearance for the Atlas™ Humeral Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthopedic Designs North America, Inc. (Odi-Na) (Tampa, US). The FDA issued a Cleared decision on November 5, 2024 after a review of 165 days - an extended review 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: 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 Orthopedic Designs North America, Inc. (Odi-Na) devices

Submission Details

510(k) Number K241484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2024
Decision Date November 05, 2024
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 262
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K241484.
Affixus Tibial Nailing System - 4mm screws
K243907 · Zimmer, Inc. · Feb 2025
Arthrex Intramedullary Nails
K243890 · Arthrex, Inc. · Jan 2025
TRIGEN META-TAN Trochanteric Antegrade Nail
K243364 · Smith & Nephew, Inc. · Dec 2024
Affixus Tibial and Antegrade Femoral Nailing System
K241651 · Zimmer, Inc. · Sep 2024
Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
K230071 · Tdm Co., Ltd. · Aug 2024
Phantom Fibula Nail System
K234128 · Paragon 28, Inc. · Aug 2024