Cleared Traditional

K113388 - CITIEFFE-TITANIUM CANNULATED SCREW

K113388 is an FDA 510(k) clearance for CITIEFFE-TITANIUM CANNULATED SCREW, manufactured by Citieffe. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K113388 · Citieffe · Orthopedic device
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Jun 2012
Decision
202d
Days
Class 2
Risk

K113388 is an FDA 510(k) clearance for the CITIEFFE-TITANIUM CANNULATED SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Citieffe (Ormond Beach, US). The FDA issued a Cleared decision on June 5, 2012 after a review of 202 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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.

FDA 510(k) Submission Details - K113388

510(k) Number K113388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2011
Decision Date June 05, 2012
Days to Decision 202 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 122d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 1056
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K113388.
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D
K121148 · Medical Design, LLC · Aug 2012
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
K121349 · Extremity Medical, LLC · Jul 2012
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
K121417 · Extremity Medical, LLC · Jul 2012
I-FUSE HAMMER TOE SYSTEMS
K113006 · Orthopro, LLC · May 2012
MINI CANNULATED HEADED AND HEADLESS SCREW SET
K120493 · Instratek, Inc. · May 2012
HEALIX ADVANCE PEEK ANCHOR
K120449 · Depuy Mitek · May 2012
K113388 · CITIEFFE-TITANIUM CANNULATED SCREW
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