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Extremity Medical, LLC

United States·US-MF-000018334

Last updated September 17, 2026

What Extremity Medical, LLC makes

Extremity Medical produces orthopaedic fixation hardware, including non-bioabsorbable bone screws (both standard and non-sliding), fixation plates, and implantable bone washers for fracture stabilization. Their portfolio also includes a total wrist prosthesis for joint replacement and reusable sterilization/disinfection containers for medical devices. Additionally, they manufacture noninvasive components for external orthopaedic fixation systems.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Extremity Medical, LLC primarily manufacture?

Extremity Medical, LLC specializes in orthopaedic fixation devices. Their portfolio includes non-bioabsorbable bone screws (both standard and non-sliding types), fixation plates, implantable bone washers, and a total wrist prosthesis for joint replacement. They also produce reusable sterilization/disinfection containers for medical devices and noninvasive components for external orthopaedic fixation systems. These devices are designed to stabilize fractures and support bone healing.

Where is Extremity Medical, LLC based, and what does that mean for their regulatory oversight?

Extremity Medical, LLC is based in the United States. Since they operate within the U.S., their devices are subject to FDA regulations, including classification under FDA’s Class I and Class II categories. This means their products must comply with FDA requirements for safety and effectiveness, though individual devices—not the company—are authorized for use.

Which regulatory registries or databases list Extremity Medical’s devices?

Extremity Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and clinical purposes. This listing is part of the broader FDA compliance process for devices classified under Class I and Class II.

How are Extremity Medical’s devices classified by the FDA, and why does this matter?

Extremity Medical’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. This classification determines the regulatory pathway and scrutiny each device undergoes before authorization, ensuring appropriate oversight based on potential risk.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
300, Interpace Parkway, Parsippany, United States
Website
extremitymedical.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
—
PRRC Contact
Brian Smekal
EUDAMED SRN
US-MF-000018334
FDA FEI Number
3007289093
DUNS Number
—

Catalogue (1433)

Page 29 of 29
DeviceModel / ReferenceRegistriesClassStatus
CompressX 101-65065-2
FDA UDI
Class IIActive
IO Freedom 147-35220
FDA UDI
Class IIActive
Omni Stable AF 144-35042
EUDAMEDFDA UDI
Class IIActive
Extremity Medical Compression Screw K081934
FDA 510(k)
Class IIActive
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System K171018
FDA 510(k)
Class IIActive
AlignX Ankle Fusion System K181067
FDA 510(k)
Class IIActive
Io Fix Hand, Io Fix Foot, Extremity Medical Screw System K101700
FDA 510(k)
Class IIActive
Extremity Medical Calcaneal Osteotomy Device K150309
FDA 510(k)
Class IIActive
Extremity Medical Calcaneal Osteotomy Device K143402
FDA 510(k)
Class IIActive
Omni Foot Plating System K172260
FDA 510(k)
Class IIActive
Omni Foot and Ankle Plating System K212297
FDA 510(k)
Class IIActive
Extremity Medical Suture Anchor K083151
FDA 510(k)
Class IIActive
Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw System K091577
FDA 510(k)
Class IIActive
Xmcp, Hallux, Tarsx, Extremity Medical Screw System K121417
FDA 510(k)
Class IIActive
MetaFore Small Screw System K250536
FDA 510(k)
Class IIActive
Extremity Medical Midfoot Screw System K082934
FDA 510(k)
Class IIActive
Extremity Medical External Fixation System K251128
FDA 510(k)
Class IIActive
Axis Charcot Fixation System K211261
FDA 510(k)
Class IIActive
Omni Foot and Ankle Plating System K221362
FDA 510(k)
Class IIActive
HammerFiX Device K152710
FDA 510(k)
Class IIActive
Extremity Medical Hammertoe Device K133636
FDA 510(k)
Class IIActive
Align Anterior Ankle Fusion Plate K160191
FDA 510(k)
Class IIActive
Extremity Medical Suture Anchor K150166
FDA 510(k)
Class IIActive
Extremity Medical Screw System K093770
FDA 510(k)
Class IIActive
Extremity Medical Trapezium Prosthesis K092548
FDA 510(k)
Class IIActive
Intraosseous Fixation System K201556
FDA 510(k)
Class IIActive
Extremity Medical External Fixation System K241563
FDA 510(k)
Class IIActive
KinematX Total Wrist Arthroplasty System K191525
FDA 510(k)
Class IIActive
Io Fix, Io Fix Plus, Carpalfix, Extremity Medical Screw And Washer K121349
FDA 510(k)
Class IIActive
Omni Foot Plating System K180808
FDA 510(k)
Class IIActive
Axis Plating System K192592
FDA 510(k)
Class IIActive
Extremity Medical Ip Fusion System K130120
FDA 510(k)
Class IIActive
IO FiX 118-46614
EUDAMEDFDA UDI
Class IIbActive

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FDA Recalls (4)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Extremity Medical, LLC has four FDA recall records initiated between April 13, 2011, and January 10, 2013, all marked as terminated. The reasons cited include discrepancies in lag screw measurements due to device calibration, a broken reamer during surgery without pre-drilling, lag screws passing through washers intra-operatively, and undersized guidewires affecting depth gauge accuracy for screw length selection.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Jan 10, 2013Z-0952-2013—terminated

The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.

Mar 22, 2012Z-0752-2013—terminated

Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).

Apr 25, 2011Z-0438-2013—terminated

Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.

Apr 13, 2011Z-0344-2013—terminated

Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.