Cleared Traditional

K113387 - CITIEFFE TITANIUM NAILING SYSTEM

K113387 is an FDA 510(k) clearance for CITIEFFE TITANIUM NAILING SYSTEM, manufactured by Citieffe. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K113387 · Citieffe · Orthopedic device
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Mar 2012
Decision
120d
Days
Class 2
Risk

K113387 is an FDA 510(k) clearance for the CITIEFFE TITANIUM NAILING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Citieffe (Ormond Beach, US). The FDA issued a Cleared decision on March 15, 2012 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Citieffe devices

FDA 510(k) Submission Details - K113387

510(k) Number K113387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2011
Decision Date March 15, 2012
Days to Decision 120 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 385
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K113387.
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S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL
K113409 · Howmedica Osteonics Corp. · Feb 2012
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
K120083 · Synthes (Usa) · Feb 2012