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Axsos 3 Ti Locking Plate System Line Extension

by Stryker Trauma AG

510(k) K133440

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)SESE Substantially Equivalent · Special NumberK133440 Date18 Dec 2013ClearedStatusActive

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  • Withdrawn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
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The Axsos 3 Ti Locking Plate System Line Extension is a titanium locking plate designed for long bone fracture fixation, including periarticular tibial fractures. It accommodates both locking and non‑locking screws in the metaphysis and shaft, providing a well‑fitting implant for areas with limited soft‑tissue coverage.

The system is supplied as a line extension of the Axsos 3 series and is cleared under FDA 510(k) as a special, substantially equivalent device (product code HWC, K133440). It is intended for use in orthopedic surgery, is provided sterile, and is a single‑use implant that conforms to the specifications of the original system.

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Questions

AI-generated answers, 22 Sep 2026

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

  • What types of fractures is the AXSOS 3 Ti Locking Plate System Line Extension intended to treat?

    It is designed for fixation of long‑bone fractures, including periarticular tibial fractures. The plate’s geometry and screw options allow stable fixation in both metaphyseal and diaphyseal regions, making it suitable for fractures where soft‑tissue coverage is limited.

  • How is the plate supplied and what sterility level does it have?

    The device is provided sterile, packaged for immediate use in the operating room. Sterile packaging ensures that the titanium plate remains free of microbial contamination until the surgeon opens it, supporting infection control protocols.

  • Is the AXSOS 3 Ti Locking Plate a single‑use implant or can it be reused?

    It is a single‑use implant. After implantation, the plate is not intended for re‑sterilization or reuse because the material properties and surface integrity could be altered, potentially compromising fixation strength and patient safety.

  • Can the plate accommodate both locking and non‑locking screws?

    Yes, the plate accepts both locking and non‑locking screws in the metaphysis and shaft. This flexibility allows the surgeon to choose the most appropriate fixation strategy for the specific fracture pattern and bone quality.

  • How does this line extension differ from the original AXSOS 3 system?

    The line extension adds new plate lengths and configurations to the existing AXSOS 3 series while maintaining the same titanium material and screw compatibility. It is cleared as a special, substantially equivalent device, meaning it conforms to the original system’s specifications but expands the inventory of available sizes.