Cleared Traditional

MODULAR ARTHRODESIS NAIL (K042409) - FDA 510(k) Clearance

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

K042409 · Biomet, Inc. · Orthopedic device
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Dec 2004
Decision
90d
Days
Class 2
Risk

K042409 is an FDA 510(k) clearance for the MODULAR ARTHRODESIS NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 2, 2004 after a review of 90 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 Biomet, Inc. devices

Submission Details

510(k) Number K042409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2004
Decision Date December 02, 2004
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 256
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K042409.
T2 RECON NAIL SYSTEM
K051624 · Howmedica Osteonics Corp. · Jul 2005
GAMMA3 NAIL SYSTEM
K043431 · Howmedica Osteonics Corp. · Feb 2005
MODIFICATION TO T2 PROXIMAL HUMERAL NAIL
K043404 · Howmedica Osteonics Corp. · Dec 2004
TRIGEN HINDFOOT FUSION NAIL
K043052 · Smith & Nephew, Inc. · Nov 2004
T2 PROXIMAL HUMERAL NAIL
K042396 · Howmedica Osteonics Corp. · Oct 2004
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)
K042135 · Synthes (Usa) · Oct 2004