Cleared Traditional

ITST Intertrochanteric/Subtrochanteric Fixation System (K143321) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K143321 · Zimmer, Inc. · Orthopedic device
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May 2015
Decision
191d
Days
Class 2
Risk

K143321 is an FDA 510(k) clearance for the ITST Intertrochanteric/Subtrochanteric Fixation System. 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 May 29, 2015 after a review of 191 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K143321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2014
Decision Date May 29, 2015
Days to Decision 191 days
Submission Type Traditional
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
69d slower than avg
Panel avg: 122d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K143321.
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MICRONAIL Distal Radius System
K150073 · Wrightmedicaltechnologyinc · Feb 2015
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
K142281 · Zimmer, Inc. · Oct 2014
VALOR Hindfoot Fusion Nail System
K142602 · Wrightmedicaltechnologyinc · Oct 2014