Cleared Special

Piccolo Composite® Nailing System (K153536) - FDA 510(k) Clearance

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

K153536 · CarboFix Orthopedics , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K153536.
AUTOBAHN Nailing System
K171108 · Globus Medical, Inc. · Dec 2017
Zimmer Natural Nail System
K172114 · Zimmer, Inc. · Aug 2017
TRIGEN Low Profile Bone Screws
K161264 · Smith & Nephew, Inc. · Nov 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