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Bone Screw 3.5 mm

FDA 510(k)

Class II (US FDA 510(k))

510(k) K915613

by Acu Med, Inc.

Identifiers

510(k) Number
K915613 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
SN FDA 510(k)

A 3.5 mm bone screw, classified under the product code HWC, is an orthopedic fixation device designed for internal stabilization of bone fractures or joint fusions. Its headless compression design reduces prominence and minimizes soft tissue irritation, improving patient comfort and reducing infection risk compared to traditional fixation methods.

The Bone Screw 3.5 mm is supplied sterile and intended for single-use in orthopedic surgical settings. It is regulated under FDA 510(k) clearance (K915613) and falls under the Orthopedic advisory committee classification. Available in a fixed 3.5 mm diameter, it is packaged for surgical use and must be handled according to sterile procedure protocols.

Frequently asked questions

What types of bone procedures is the 3.5 mm bone screw designed to assist with, and why is its headless design considered an advantage?

The 3.5 mm bone screw is designed for internal stabilization of bone fractures or joint fusions, helping to secure bone segments during healing. Its headless compression design is an advantage because it reduces prominence under the skin, minimizing soft tissue irritation and lowering the risk of infection compared to traditional screws with protruding heads.

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

The 3.5 mm bone screw is supplied sterile and intended for single-use only in orthopedic surgical settings. To maintain sterility, it must be handled using sterile procedure protocols, as with all single-use surgical devices.

What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed this submission?

The Bone Screw 3.5 mm received FDA clearance through a Traditional 510(k) pathway (K915613) and was classified under the Orthopedic Advisory Committee (OR). The submission was determined substantially equivalent for some indications, as noted in the decision documentation.

Are there different sizes or models available for this screw, or is it a fixed 3.5 mm diameter?

This screw is supplied in a fixed 3.5 mm diameter only—no other sizes or models are available. The design is standardized for consistent use in orthopedic fixation procedures.

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: Bone Screw 3.5 MM - Extremity Screw System 510K - Acumed, Screw & Pin - Acumed Information, Calcaneus compression bone screw - Acutrak 2 - Acumed - MedicalExpo, BONE SCREW 3.5 MM (K915613) — FDA 510 (k) | Innolitics

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) K915613 24 fields · synced Sep 19, 2026