Cleared Special

K040462 - TRIGEN TROCHANTERIC ANTEGRADE NAIL

K040462 is an FDA 510(k) clearance for TRIGEN TROCHANTERIC ANTEGRADE NAIL, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K040462

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.

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 530
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K040462.
FASSIER-DUVAL TELSCOPIC IM SYSTEM
K041393 · Pega Medical, Inc. · Aug 2004
TRIGEN ADOLESCENT TAN
K040929 · Smith & Nephew, Inc. · May 2004
SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
K040336 · Synthes (Usa) · Apr 2004
ACE PROXIMAL HUMERAL NAIL SYSTEM
K033806 · Depuy Ace · Feb 2004
ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM
K033878 · Depuy Ace · Feb 2004
SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
K033618 · Synthes (Usa) · Feb 2004
K040462 · TRIGEN TROCHANTERIC ANTEGRADE NAIL
Download PDF FDA Summary Smith & Nephew, Inc.