Cleared Special

K152710 - HammerFiX Device

K152710 is the FDA 510(k) clearance for HammerFiX Device by Extremity Medical, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 24-day FDA review.

K152710 · Extremity Medical, LLC · Orthopedic device
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Oct 2015
Decision
24d
Days
Class 2
Risk

K152710 is an FDA 510(k) clearance for the HammerFiX Device. 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 October 15, 2015 after a review of 24 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

Submission Details

510(k) Number K152710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2015
Decision Date October 15, 2015
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 620
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K152710.
Tyber Medical Trauma Screw
K153575 · Tyber Medical, LLC · Feb 2016
Tyber Medical MST Trauma Screw
K153180 · Tyber Medical, LLC · Nov 2015
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
K152841 · Zimmer, Inc. · Nov 2015
PRO-TOE Hammertoe Fixation System
K151838 · Wrightmedicaltechnologyinc · Sep 2015
ForeFoot STP System
K150871 · Tornier, Inc. · Aug 2015
Arthrex RetroFusion Screw
K151078 · Arthrex, Inc. · May 2015