Cleared Special

ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL (K032367) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032367 · Zimmer, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2003
Decision
11d
Days
Class 2
Risk

K032367 is an FDA 510(k) clearance for the ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 12, 2003 after a review of 11 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 Zimmer, Inc. devices

Submission Details

510(k) Number K032367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2003
Decision Date August 12, 2003
Days to Decision 11 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
111d faster than avg
Panel avg: 122d · This submission: 11d
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 256
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K032367.
T2 RECON NAIL SYSTEM
K032898 · Howmedica Osteonics Corp. · Oct 2003
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
K032722 · Smith & Nephew, Inc. · Oct 2003
S2 NAIL SYSTEM
K032579 · Howmedica Osteonics Corp. · Aug 2003
DEPUY ACE VERSANAIL TIBIAL NAIL
K032097 · DePuy Orthopaedics, Inc. · Aug 2003
GAMMA 3 NAIL SYSTEM
K032244 · Howmedica Osteonics Corp. · Aug 2003
ACE VERSANAIL
K023115 · DePuy Orthopaedics, Inc. · Dec 2002