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Acumed Small Bone Locking Rod System II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031438

by Acumed, LLC

Identifiers

510(k) Number
K031438 FDA 510(k)
FDA Product Code
HSB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3020 FDA 510(k)
Regulation Number
888.3020 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Acumed Small Bone Locking Rod System II is an intramedullary fixation device classified as a Bone Locking Rod (Nomenclature Code: HSB). It is designed for internal stabilization of long bone fractures and osteotomies in the fibula, radius, and ulna, utilizing solid or cannulated rods and cortical screws to provide rigid fixation.

This system is supplied as a sterile, single-use orthopedic implant and is intended for use in surgical settings. The rods, ranging in length and diameters of 3.0–4.5 mm, are slightly bowed to conform to bone anatomy. The device holds FDA 510(k) clearance (K031438) under the Traditional 510(k) review pathway, with no third-party involvement. Storage and handling must comply with sterile surgical instrument protocols.

Frequently asked questions

What bones is this locking rod system specifically designed to stabilize, and how does its design accommodate them?

The Acumed Small Bone Locking Rod System II is designed for internal stabilization of fractures and osteotomies in the fibula, radius, and ulna. Its rods are slightly bowed to conform to the natural curvature of these long bones, ensuring a better fit and more effective fixation when secured with cortical screws.

Is this device reusable, or is it intended for single-use only? How should it be handled to maintain sterility?

This system is sterile and single-use only, meaning it must not be reused after a single surgical procedure. Since it is classified as an orthopedic implant, it follows standard sterile surgical instrument protocols for storage and handling to prevent contamination.

What rod sizes are available, and how might a clinician choose the appropriate one for a patient?

The rods come in lengths with diameters ranging from 3.0 mm to 4.5 mm, allowing for flexibility in treating different bone sizes and fracture patterns. The choice depends on the specific anatomy of the fibula, radius, or ulna being treated, as well as the surgeon’s assessment of stability needs—smaller diameters may be used for pediatric or smaller adult bones, while larger diameters provide added rigidity for complex fractures.

How is this device regulated, and what does the FDA clearance indicate about its safety and effectiveness?

The Acumed Small Bone Locking Rod System II holds FDA 510(k) clearance (K031438) under the Traditional review pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that the FDA has reviewed its design, manufacturing processes, and clinical rationale to confirm it meets applicable safety and effectiveness standards for internal fixation of long bone fractures.

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: ACUMED SMALL BONE LOCKING ROD SYSTEM II (K031438) — FDA 510 (k ..., ACUMED SMALL BONE LOCKING SYSTEM II - Innolitics, PDF RC:IUmEDLLC 2007 - Food and Drug Administration, PDF K071944 - Acumed Small Bone Locking System Ii, Acumed Small Bone Fixator - Wheeless' Textbook of Orthopaedics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acumed, LLC

Sources (1)

  • FDA 510(k) K031438 24 fields · synced Sep 19, 2026