Cleared Traditional

K241651 - Affixus Tibial and Antegrade Femoral Na...

K241651 is the FDA 510(k) clearance for Affixus Tibial and Antegrade Femoral Na... by Zimmer, Inc.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 322
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