Cleared Traditional

K241651 - Affixus Tibial and Antegrade Femoral Nailing System

K241651 is an FDA 510(k) clearance for Affixus Tibial and Antegrade Femoral Na..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K241651 · Zimmer, Inc. · Orthopedic device
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Sep 2024
Decision
111d
Days
Class 2
Risk

K241651 is an FDA 510(k) clearance for the Affixus Tibial and Antegrade Femoral Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 26, 2024 after a review of 111 days - within the typical 510(k) review window.

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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K241651

510(k) Number K241651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2024
Decision Date September 26, 2024
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K241651.
Arthrex Intramedullary Nails
K243890 · Arthrex, Inc. · Jan 2025
TRIGEN META-TAN Trochanteric Antegrade Nail
K243364 · Smith & Nephew, Inc. · Dec 2024
Atlas™ Humeral Nail System
K241484 · Orthopedic Designs North America, Inc. (Odi-Na) · Nov 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
DePuy Synthes Retrograde Femoral Nail Advanced System
K233696 · DePuy Synthes · Aug 2024