Cleared Special

K121417 - XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM

K121417 is an FDA 510(k) clearance for XMCP, 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 68-day FDA review.

K121417 · Extremity Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2012
Decision
68d
Days
Class 2
Risk

K121417 is an FDA 510(k) clearance for the XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM. 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 68 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 - K121417

510(k) Number K121417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2012
Decision Date July 18, 2012
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 K121417.
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
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
K121349 · Extremity Medical, LLC · Jul 2012
CITIEFFE-TITANIUM CANNULATED SCREW
K113388 · Citieffe · Jun 2012
I-FUSE HAMMER TOE SYSTEMS
K113006 · Orthopro, LLC · May 2012
MINI CANNULATED HEADED AND HEADLESS SCREW SET
K120493 · Instratek, Inc. · May 2012