Cleared Special

K131005 - EBA2 FEMORAL NAILING SYSTEM

K131005 is an FDA 510(k) clearance for EBA2 FEMORAL NAILING SYSTEM, manufactured by Citieffe S.R.L.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 75-day FDA review.

K131005 · Citieffe S.R.L. · Orthopedic device
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Jun 2013
Decision
75d
Days
Class 2
Risk

K131005 is an FDA 510(k) clearance for the EBA2 FEMORAL NAILING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Citieffe S.R.L. (Ormond Beach, US). The FDA issued a Cleared decision on June 25, 2013 after a review of 75 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 Citieffe S.R.L. devices

FDA 510(k) Submission Details - K131005

510(k) Number K131005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2013
Decision Date June 25, 2013
Days to Decision 75 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
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 366
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K131005.
PICCOLO COMPOSITE NAILING SYSTEM
K132774 · CarboFix Orthopedics , Ltd. · 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
PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
K123810 · CarboFix Orthopedics , Ltd. · Jun 2013
ANTEGRADE FEMORAL NAIL
K123569 · Advanced Orthopaedic Solutions, Inc. · May 2013
12MM AND 13MM TIBIAL NAILS
K130625 · Advanced Orthopaedic Solutions, Inc. · Mar 2013