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Aesculap Titanium Bone Screws

by Aesculap, Inc.

510(k) K913415

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK913415 Date29 Oct 1991DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aesculap Titanium Bone Screws are orthopedic fixation devices designed for internal bone stabilization. These screws are manufactured from pure titanium and comply with ISO 5832/II standards, providing a reliable solution for securing bone fragments or implants during surgical procedures. Available in various diameters, lengths, and thread designs—including cortical and cancellous—they are tailored for different anatomical applications and fixation requirements.

These screws are supplied sterile and intended for single-use in orthopedic surgeries. They are classified under FDA product code HWC and were granted a 510(k) clearance (K913415) in 1991, with a determination of Substantially Equivalent for Some Indications by the Orthopedic (OR) Advisory Committee. Storage and handling must adhere to sterile medical device protocols to ensure integrity prior to use.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the Aesculap Titanium Bone Screws used for?

    These screws are designed for internal bone stabilization during orthopedic surgeries. They securely fix bone fragments or implants, ensuring proper alignment and healing. The pure titanium construction and compliance with ISO 5832/II standards make them reliable for applications requiring durable fixation.

  • Are the screws supplied sterile and for single-use?

    Yes, the Aesculap Titanium Bone Screws are supplied sterile and intended exclusively for single-use. This ensures patient safety and maintains sterility throughout the surgical procedure, adhering to medical device handling protocols.

  • What thread designs are available for these screws?

    The screws come in two thread designs: cortical and cancellous. Cortical screws are optimized for dense bone surfaces, while cancellous screws are designed for softer, spongy bone. This variety allows clinicians to select the appropriate screw for the anatomical site and fixation requirements.

  • How should these screws be stored before use?

    Storage must follow sterile medical device protocols to preserve integrity. The packaging should remain unopened until immediately before use, and the screws should be handled with care to avoid contamination. Proper storage ensures the sterility and functionality of the device.

  • What regulatory clearance does this product hold?

    The Aesculap Titanium Bone Screws hold an FDA 510(k) clearance (K913415) under product code HWC, granted in 1991. The Orthopedic Advisory Committee determined the device as Substantially Equivalent for Some Indications, validating its use in specific orthopedic applications.