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Orthopaedic Wires

FDA 510(k)

Class II (US FDA 510(k))

510(k) K942603

by Acu Med, Inc.

Identifiers

510(k) Number
K942603 FDA 510(k)
FDA Product Code
LRN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Orthopaedic Wires are classified as Wire, Surgical under FDA regulation 888.3030. These devices are designed for internal fixation of fractures, providing mechanical stability through tension band wiring or cerclage techniques to support bone alignment during healing. They are intended for orthopaedic applications where secure fixation is required to maintain proper bone positioning.

Orthopaedic Wires are supplied as single-use devices and are regulated under FDA 510(k) clearance (K942603) with a classification of Class II. They are intended for use in sterile surgical environments and are distributed under the product code LRN. No third-party review was conducted, and the device was determined to be substantially equivalent to the predicate. Storage and handling follow standard orthopaedic surgical protocols to ensure sterility and integrity prior to use.

Frequently asked questions

What types of fractures are these orthopaedic wires designed to stabilize, and how do they achieve this stability?

These Orthopaedic Wires are specifically designed for internal fixation of fractures using tension band wiring or cerclage techniques. They provide mechanical stability by securing bone fragments together, ensuring proper alignment during the healing process. This is particularly useful in orthopaedic applications where maintaining bone positioning is critical, such as in certain types of long bone fractures or joint dislocations.

Are these wires reusable, or are they intended for single-use only? How should they be handled to maintain sterility?

The Orthopaedic Wires are explicitly supplied as single-use devices. To maintain sterility and integrity before use, they must be handled according to standard orthopaedic surgical protocols. This includes keeping them in their sterile packaging until the moment of use and ensuring the surgical environment remains sterile throughout the procedure.

What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians using the device?

The Orthopaedic Wires were cleared through the FDA’s 510(k) process (K942603) under the classification of Class II, with a determination of substantial equivalence to a predicate device. This means the device was reviewed by the FDA to ensure it is as safe and effective as a legally marketed alternative, and clinicians can rely on its regulatory clearance as a marker of compliance with FDA standards for orthopaedic fixation wires.

What sizes or models of these wires are available, and how do clinicians determine the appropriate one for a patient?

While the exact sizes or model variations are not detailed in the provided data, the Orthopaedic Wires are listed under multiple registration numbers (e.g., 8043792, 9616680, etc.) and FEI numbers, suggesting a range of gauges or diameters may be available. Clinicians typically select the appropriate size based on the specific fracture type, bone anatomy, and surgical technique—such as tension band wiring or cerclage—following established orthopaedic guidelines.

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: Orthopaedic Wires - Acu Med | FDA Evidence Review, ORTHOPAEDIC WIRES (K942603) — FDA 510 (k) | Innolitics, ORTHOPAEDIC WIRES 510 (k) K942603 - FDA.report, PDF K942603 - Orthopaedic Wires

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acu Med, Inc.

Sources (1)

  • FDA 510(k) K942603 24 fields · synced Sep 20, 2026