Cleared Traditional

K042332 - TITANIUM TELEGRAPH HUMERAL NAIL

K042332 is an FDA 510(k) clearance for TITANIUM TELEGRAPH HUMERAL NAIL, manufactured by Fournitures Hospitalieres Industrie. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K042332 · Fournitures Hospitalieres Industrie · Orthopedic device
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Oct 2004
Decision
38d
Days
Class 2
Risk

K042332 is an FDA 510(k) clearance for the TITANIUM TELEGRAPH HUMERAL NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Fournitures Hospitalieres Industrie (Quimper Finistere, FR). The FDA issued a Cleared decision on October 7, 2004 after a review of 38 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 Fournitures Hospitalieres Industrie devices

FDA 510(k) Submission Details - K042332

510(k) Number K042332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2004
Decision Date October 07, 2004
Days to Decision 38 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
84d faster than avg
Panel avg: 122d · This submission: 38d
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 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K042332.
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
TROCHANTERIC NAIL SYSTEM
K042325 · DePuy Orthopaedics, Inc. · Sep 2004
TRIGEN ADOLESCENT TAN
K040929 · Smith & Nephew, Inc. · May 2004
SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
K040336 · Synthes (Usa) · Apr 2004