Cleared Traditional

K143496 - Piccolo Composite Plate System

K143496 is an FDA 510(k) clearance for Piccolo Composite Plate System, manufactured by CarboFix Orthopedics , Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K143496 · CarboFix Orthopedics , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
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May 2015
Decision
171d
Days
Class 2
Risk

K143496 is an FDA 510(k) clearance for the Piccolo Composite 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. (Herzliya, IL). The FDA issued a Cleared decision on May 29, 2015 after a review of 171 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 CarboFix Orthopedics , Ltd. devices

FDA 510(k) Submission Details - K143496

510(k) Number K143496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2014
Decision Date May 29, 2015
Days to Decision 171 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
49d slower than avg
Panel avg: 122d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1222
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K143496.
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Metallic Locking Bone Plate and Screw System
K143002 · Changzhou Dingjian Medical Appliance Co., Ltd. · Jun 2015
BIOFOAM Bone Wedge
K142724 · Wrightmedicaltechnologyinc · May 2015
Dorsal Spanning Plate
K150675 · Skeletal Dynamics, LLC · May 2015
G3 Active Plate Large Fragment System
K150649 · Genesis Fracture Care, Inc. · Apr 2015