Cleared Traditional

K170401 - Piccolo Composite® Plate System

K170401 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 92-day FDA review.

K170401 · CarboFix Orthopedics , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
92d
Days
Class 2
Risk

K170401 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. (Herzeliya, IL). The FDA issued a Cleared decision on May 12, 2017 after a review of 92 days - within the typical 510(k) review window.

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 - K170401

510(k) Number K170401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2017
Decision Date May 12, 2017
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 1245
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K170401.
BioPro Foot Plating Systems
K162674 · Biopro, Inc. · Jun 2017
Alians Fragment Specific
K170843 · Newclip Technics · Jun 2017
EVOS Small Fragment Lower Extremity Plates
K170457 · Smith & Nephew, Inc. · Jun 2017
VariAx 2 Foot System
K170771 · Stryker GmbH · May 2017
Colink™ Plating System
K163293 · In2bones USA, LLC · May 2017
Locking Plate System
K162380 · Beijing Keyi Medical Device Technology Co., Ltd. · May 2017