Cleared Special

K132774 - PICCOLO COMPOSITE NAILING SYSTEM

K132774 is an FDA 510(k) clearance for PICCOLO COMPOSITE NAILING SYSTEM, manufactured by CarboFix Orthopedics , Ltd.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 28-day FDA review.

K132774 · CarboFix Orthopedics , Ltd. · Orthopedic device
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Oct 2013
Decision
28d
Days
Class 2
Risk

K132774 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. (Herzliya, IL). The FDA issued a Cleared decision on October 3, 2013 after a review of 28 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

FDA 510(k) Submission Details - K132774

510(k) Number K132774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2013
Decision Date October 03, 2013
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HSB Device Classification - Class 2, Special Controls

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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K132774.
AEQUALIS HUMERAL NAIL
K133376 · Tornier, Inc. · Dec 2013
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K131677 · Ellipse Technologies, Inc. · Oct 2013
T2 TIBIAL NAILING SYSTEM
K131365 · Stryker Trauma AG · Oct 2013
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
K130595 · Zimmer, Inc. · Sep 2013
RETROGRADE FEMORAL NAIL
K132005 · Advanced Orthopaedic Solutions, Inc. · Sep 2013
611 ANKLE FUSION NAIL
K130051 · Tornier S.A.S. · Jul 2013