Cleared Special

K033510 - MODIFICATION TO TELEGRAPH HUMERAL NAIL

K033510 is an FDA 510(k) clearance for MODIFICATION TO TELEGRAPH HUMERAL NAIL, manufactured by Fournitures Hospitalieres Industrie. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 27-day FDA review.

K033510 · Fournitures Hospitalieres Industrie · Orthopedic device
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Dec 2003
Decision
27d
Days
Class 2
Risk

K033510 is an FDA 510(k) clearance for the MODIFICATION TO 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 December 3, 2003 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fournitures Hospitalieres Industrie devices

FDA 510(k) Submission Details - K033510

510(k) Number K033510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2003
Decision Date December 03, 2003
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K033510.
TRIGEN TROCHANTERIC ANTEGRADE NAIL
K040462 · Smith & Nephew, Inc. · Mar 2004
SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
K033618 · Synthes (Usa) · Feb 2004
GAMMA3 NAIL SYSTEM
K034002 · Howmedica Osteonics Corp. · Jan 2004
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
K033329 · Depuy, Inc. · Nov 2003
T2 NAILING SYSTEM
K032523 · Howmedica Osteonics Corp. · Oct 2003
T2 RECON NAIL SYSTEM
K032898 · Howmedica Osteonics Corp. · Oct 2003