Cleared Traditional

K120409 - PICCOLO COMPOSITE PLATE SYSTEM

K120409 is the FDA 510(k) clearance for PICCOLO COMPOSITE PLATE SYSTEM by CarboFix Orthopedics , Ltd.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K120409 · CarboFix Orthopedics , Ltd. · Orthopedic device
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Nov 2012
Decision
291d
Days
Class 2
Risk

K120409 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 November 26, 2012 after a review of 291 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

Submission Details

510(k) Number K120409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2012
Decision Date November 26, 2012
Days to Decision 291 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 122d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 903
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K120409.
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055 · Smith & Nephew, Inc. · Jan 2013
INTEGRA TOTAL FOOT SYSTEMS
K123000 · Integra LifeSciences Corporation · Dec 2012
LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
K121495 · Aap Implantate AG · Dec 2012
LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING
K121494 · Aap Implantate AG · Nov 2012
ACUMED PELVIC BONE PLATE SYSTEM
K122538 · Acumed, LLC · Nov 2012
KLS MARTIN RECON TALON
K122860 · KLS-Martin L.P. · Nov 2012