Cleared Special

K153536 - Piccolo Composite Nailing System

K153536 is the FDA 510(k) clearance for Piccolo Composite Nailing System by CarboFix Orthopedics , Ltd.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Special 510(k) pathway after a 27-day FDA review.

K153536 · CarboFix Orthopedics , Ltd. · Orthopedic device
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Jan 2016
Decision
27d
Days
Class 2
Risk

K153536 is an FDA 510(k) clearance for the Piccolo Composite® Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by CarboFix Orthopedics , Ltd. (Herzeliya, IL). The FDA issued a Cleared decision on January 6, 2016 after a review of 27 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 CarboFix Orthopedics , Ltd. devices

Submission Details

510(k) Number K153536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2015
Decision Date January 06, 2016
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 337
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K153536.
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
K161466 · Orthofix Srl · Jan 2017
TRIGEN Low Profile Bone Screws
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DePuy Synthes TFNA Augmentation System
K160167 · Synthes USA Products, LLC · Sep 2016
Cardinal Health Trochanteric IM Nail System
K150769 · Cardinalhealth · Dec 2015
Piccolo Composite Nailing System
K151010 · CarboFix Orthopedics , Ltd. · Jul 2015
Affixus Tibial Nailing System
K150867 · Biomet, Inc. · Jun 2015