Cleared Traditional

K243907 - Affixus Tibial Nailing System - 4mm screws

K243907 is the FDA 510(k) clearance for Affixus Tibial Nailing System - 4mm screws by Zimmer, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K243907 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
55d
Days
Class 2
Risk

K243907 is an FDA 510(k) clearance for the Affixus Tibial Nailing System - 4mm screws. 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 February 12, 2025 after a review of 55 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 Zimmer, Inc. devices

Submission Details

510(k) Number K243907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2024
Decision Date February 12, 2025
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 318
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K243907.
FitboneTM Trochanteric
K250112 · Orthofix Srl · Apr 2025
Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
K250623 · OrthoPediatrics Corp. · Apr 2025
Fassier-Duval Telescoping IM System
K241983 · Orthopediatrics Canada Ulc Dba Pega Medical · Feb 2025
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