Cleared Traditional

K113006 - I-FUSE HAMMER TOE SYSTEMS

K113006 is an FDA 510(k) clearance for I-FUSE HAMMER TOE SYSTEMS, manufactured by Orthopro, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K113006 · Orthopro, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
231d
Days
Class 2
Risk

K113006 is an FDA 510(k) clearance for the I-FUSE HAMMER TOE SYSTEMS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Orthopro, LLC (Round Rock, US). The FDA issued a Cleared decision on May 25, 2012 after a review of 231 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.

View all Orthopro, LLC devices

FDA 510(k) Submission Details - K113006

510(k) Number K113006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2011
Decision Date May 25, 2012
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
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 758
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K113006.
PMT BONE SCREWS
K121713 · Providence Medical Technology, Inc. · Sep 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
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
K120645 · Wrightmedicaltechnologyinc · Apr 2012
COLS PEEK
K113591 · Fournitures Hospitalieres Industrie · Dec 2011
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885 · Zimmer, Inc. · Dec 2011