Cleared Special

K040462 - TRIGEN TROCHANTERIC ANTEGRADE NAIL

K040462 is the FDA 510(k) clearance for TRIGEN TROCHANTERIC ANTEGRADE NAIL by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Special 510(k) pathway after a 29-day FDA review.

K040462 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
29d
Days
Class 2
Risk

K040462 is an FDA 510(k) clearance for the TRIGEN TROCHANTERIC ANTEGRADE NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 23, 2004 after a review of 29 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K040462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2004
Decision Date March 23, 2004
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K040462.
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
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