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Cortical Bone Screw (European Style)

by O'Tec Corp. 510(k)

Active United States

510(k) K905357

Overview

The Cortical Bone Screw (European Style) is a threaded orthopedic fixation device designed for internal stabilization of bone fractures. It features a slotted head and is classified as a Class II medical device under FDA regulations. This screw is specifically engineered to engage cortical bone, providing secure fixation in orthopedic procedures.

Supplied as a non-sterile device, the Cortical Bone Screw (European Style) is intended for single-use applications in orthopedic surgery. It is regulated under FDA 510(k) clearance (K905357) with a decision classification of Substantially Equivalent for Some Indications. The device is distributed in sizes and configurations suitable for European-style orthopedic fixation techniques, adhering to established orthopedic standards.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK905357 Date4 Jan 1991DecidedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SN

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Questions

  • What is the Cortical Bone Screw (European Style) used for?

    This screw is designed specifically for internal stabilization of bone fractures, engaging cortical bone to provide secure fixation during orthopedic procedures. Its threaded design ensures strong attachment, making it ideal for procedures requiring reliable bone alignment and healing support.

  • Is the Cortical Bone Screw (European Style) sterile when supplied?

    No, the Cortical Bone Screw (European Style) is supplied in a non-sterile state. It is intended for single-use applications, meaning it must be sterilized by the surgical facility prior to use in a sterile field, adhering to standard orthopedic surgical protocols.

  • What sizes and configurations are available for the Cortical Bone Screw (European Style)?

    The device is distributed in sizes and configurations tailored to European-style orthopedic fixation techniques. While exact dimensions are not specified in the provided data, it is engineered to meet established European standards for cortical bone screws, ensuring compatibility with common orthopedic procedures in that region.

  • Can the Cortical Bone Screw (European Style) be reused?

    No, the Cortical Bone Screw (European Style) is explicitly intended for single-use only. Reusing a bone screw in orthopedic surgery poses significant risks, including infection, compromised fixation, and potential failure of the implant. Single-use devices are designed to minimize these risks by ensuring sterility and structural integrity for one procedure.

  • What regulatory clearance does the Cortical Bone Screw (European Style) hold?

    The Cortical Bone Screw (European Style) holds FDA 510(k) clearance under the reference number K905357. The decision classification is ‘Substantially Equivalent for Some Indications,’ meaning it has been determined to be at least as safe and effective as a legally marketed predicate device for certain applications. This clearance is specific to its intended use in orthopedic fixation.