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Extremity Medical Screw and Washer

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K121349

by Extremity Medical, LLC

Identifiers

510(k) Number
K121349 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Extremity Medical Screw and Washer is a screw and washer system designed for internal fixation of fractures, osteotomies, arthrodeses, and nonunions in the small bones and joints of the foot, ankle, hand, and wrist. It provides stabilization for both intra-articular and extra-articular injuries, ensuring proper alignment and bone healing through secure fixation.

This system is supplied as a sterile, single-use device and is intended for use in orthopedic surgical settings. It is classified under the HWC (Hardware, Orthopedic) product code and has received FDA 510(k) clearance and MDD authorization. The device is engineered for precise placement within bone, minimizing soft tissue irritation and reducing post-operative complications.

Frequently asked questions

What types of injuries or conditions is this screw and washer system specifically designed to stabilize in the foot, ankle, hand, or wrist?

This system is designed for internal fixation of fractures, osteotomies, arthrodeses, and nonunions in the small bones and joints of the foot, ankle, hand, and wrist. It provides stabilization for both intra-articular (within the joint) and extra-articular (outside the joint) injuries to ensure proper alignment and promote bone healing.

Is this device intended for reuse in clinical settings, or is it meant to be used only once per patient?

The Extremity Medical Screw and Washer system is supplied as a sterile, single-use device. This design ensures patient safety by preventing cross-contamination and maintaining sterility for each surgical procedure.

How is this device classified under regulatory frameworks, and what does that mean for its use in orthopedic surgery?

This device falls under the HWC (Hardware, Orthopedic) product code and has received FDA 510(k) clearance and MDD authorization. The clearance indicates it is deemed substantially equivalent to a legally marketed predicate device, while MDD authorization aligns with European regulatory standards. This means it is approved for use in orthopedic surgical settings for internal fixation as described.

What surgical environments or settings is this device intended for, and why is that important?

The device is explicitly intended for use in orthopedic surgical settings, where controlled, sterile conditions are maintained. This ensures proper placement, minimizes infection risk, and aligns with clinical protocols for internal fixation procedures in small bones and joints.

How does the design of this screw and washer system help reduce complications after surgery?

The system is engineered for precise bone placement, which minimizes soft tissue irritation and reduces post-operative complications like displacement or hardware failure. Its secure fixation promotes proper alignment, aiding consistent bone healing and stability.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Io Fix, Io Fix Plus, Carpalfix, Extremity Medical Screw and Washer, IO FiX 2.0 - Extremity Medical, Io Fix, Io Fix Plus, Carpalfix, Extremity Medical Screw And Washer 510 ..., K121349 FDA 510 (k) - IO FIX | Extremity Medical, LLC

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Extremity Medical, LLC

Sources (2)

  • FDA 510(k) K121349 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026