Cleared Special

K121349 - IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER

K121349 is an FDA 510(k) clearance for IO FIX, manufactured by Extremity Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 75-day FDA review.

K121349 · Extremity Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2012
Decision
75d
Days
Class 2
Risk

K121349 is an FDA 510(k) clearance for the IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on July 18, 2012 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Extremity Medical, LLC devices

FDA 510(k) Submission Details - K121349

510(k) Number K121349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2012
Decision Date July 18, 2012
Days to Decision 75 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Modification to existing cleared device.

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 985
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K121349.
ACTIVE SCREW BONE SCREW
K121682 · Intelligent Implant Systems, LLC · Oct 2012
PMT BONE SCREWS
K121713 · Providence Medical Technology, Inc. · Sep 2012
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
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
K121417 · Extremity Medical, LLC · Jul 2012
CITIEFFE-TITANIUM CANNULATED SCREW
K113388 · Citieffe · Jun 2012
I-FUSE HAMMER TOE SYSTEMS
K113006 · Orthopro, LLC · May 2012