Cleared Special

K201556 - Intraosseous Fixation System

K201556 is the FDA 510(k) clearance for Intraosseous Fixation System by Extremity Medical, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 28-day FDA review.

K201556 · Extremity Medical, LLC · Orthopedic device
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Jul 2020
Decision
28d
Days
Class 2
Risk

K201556 is an FDA 510(k) clearance for the Intraosseous Fixation 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 8, 2020 after a review of 28 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 K201556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2020
Decision Date July 08, 2020
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K201556.
Vector Hammertoe Correction System
K201850 · Nvision Biomedical Technologies, Inc. · Aug 2020
OSSIOfiber™ Compression Screws
K193660 · OSSIO , Ltd. · Jul 2020
REDUCT® Headless Compression Screw System
K201662 · Skeletal Dynamics, Inc. · Jul 2020
RetroFix
K200226 · Retrofix Screws, LLC · Jun 2020
DuoHex CH Cannulated Hammertoe System
K200840 · Nextremity Solutions, Inc. · Jun 2020
InFrame™ Cannulated Fixation System
K201430 · Exsomed Corp. · Jun 2020