Cleared Special

Piccolo Composite(R) Distal Volar Radius Plate System (K160002) - FDA 510(k) Clearance

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

K160002 · CarboFix Orthopedics , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
65d
Days
Class 2
Risk

K160002 is an FDA 510(k) clearance for the Piccolo Composite(R) Distal Volar Radius Plate System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by CarboFix Orthopedics , Ltd. (Herzeliya, IL). The FDA issued a Cleared decision on March 9, 2016 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 K160002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2016
Decision Date March 09, 2016
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K160002.
VLP Wrist Fracture System
K161665 · Smith & Nephew, Inc. · Nov 2016
Ulna Plating System
K162424 · Biomet, Inc. · Oct 2016
BIOFOAM Bone Wedge
K152062 · Wrightmedicaltechnologyinc · May 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716 · Zimmer, Inc. · Jan 2016
ORTHOLOC® 3Di Foot Plating Reconstruction System
K152974 · Wrightmedicaltechnologyinc · Dec 2015
VLP Mini-Mod Talus Plates
K152976 · Smith & Nephew, Inc. · Nov 2015