Cleared Traditional

K150769 - Cardinal Health Trochanteric IM Nail Sy...

K150769 is the FDA 510(k) clearance for Cardinal Health Trochanteric IM Nail Sy... by Cardinalhealth. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K150769 · Cardinalhealth · Orthopedic device
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Dec 2015
Decision
265d
Days
Class 2
Risk

K150769 is an FDA 510(k) clearance for the Cardinal Health Trochanteric IM Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on December 14, 2015 after a review of 265 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 Cardinalhealth devices

Submission Details

510(k) Number K150769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2015
Decision Date December 14, 2015
Days to Decision 265 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 122d · This submission: 265d
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 319
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K150769.
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
K161466 · Orthofix Srl · Jan 2017
TRIGEN Low Profile Bone Screws
K161264 · Smith & Nephew, Inc. · Nov 2016
DePuy Synthes TFNA Augmentation System
K160167 · Synthes USA Products, LLC · Sep 2016
Affixus Tibial Nailing System
K150867 · Biomet, Inc. · Jun 2015
ITST Intertrochanteric/Subtrochanteric Fixation System
K143321 · Zimmer, Inc. · May 2015
MICRONAIL Distal Radius System
K150073 · Wrightmedicaltechnologyinc · Feb 2015