Cleared Special

K032722 - TRIGEN STRAIGHT HUMERAL NAIL SYSTEM

K032722 is the FDA 510(k) clearance for TRIGEN STRAIGHT HUMERAL NAIL SYSTEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Special 510(k) pathway after a 28-day FDA review.

K032722 · Smith & Nephew, Inc. · Orthopedic device
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Oct 2003
Decision
28d
Days
Class 2
Risk

K032722 is an FDA 510(k) clearance for the TRIGEN STRAIGHT HUMERAL NAIL SYSTEM. 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 October 1, 2003 after a review of 28 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 K032722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2003
Decision Date October 01, 2003
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 K032722.
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
IP-XS COMPRESSION NAIL SYSTEM
K032548 · Plus Orthopedics · Sep 2003
S2 NAIL SYSTEM
K032579 · Howmedica Osteonics Corp. · Aug 2003
ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL
K032367 · Zimmer, Inc. · Aug 2003