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LimaCorporate Kirschner Wire

by Lima Corporate S.P.A. 510(k)

Active United States

510(k) K203475

Overview

The LimaCorporate Kirschner Wire is a Pin, Fixation, Smooth orthopedic device, classified under product code HTY. It is designed as a smooth intramedullary fixation pin used in orthopedic procedures to stabilize bone fractures by providing internal alignment and support during the healing process.

This device is supplied as a reusable medical instrument and is intended for use in sterile surgical environments. It is regulated under FDA 510(k) clearance (K203475) via the Traditional pathway, with a decision date of February 5, 2021, and is classified as a Class 2 Orthopedic device. No additional sterility or MRI safety specifications are noted in the available data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203475 Date5 Feb 2021ClearedStatusActive

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
HTY
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary purpose of the LimaCorporate Kirschner Wire in orthopedic surgery?

    The LimaCorporate Kirschner Wire is designed as a smooth intramedullary fixation pin used to stabilize bone fractures by providing internal alignment and support during the healing process. It helps maintain proper bone positioning to ensure effective fracture recovery.

  • Is the Kirschner Wire intended for single-use or can it be reused in multiple procedures?

    The Kirschner Wire is explicitly supplied as a reusable medical instrument, meaning it is intended for use in multiple procedures after proper cleaning and sterilization. It is designed for sterile surgical environments, ensuring safe reuse when handled according to medical protocols.

  • How is the regulatory status of this device determined, and what pathway was used for FDA clearance?

    The LimaCorporate Kirschner Wire received FDA clearance through the Traditional 510(k) pathway, classified as substantially equivalent (SESE) under product code HTY. The decision was made by the Orthopedic (OR) Advisory Committee on February 5, 2021, following a review process initiated on November 25, 2020.

  • Are there any special considerations for storage or handling of the Kirschner Wire?

    While specific storage instructions are not detailed in the provided data, as a reusable orthopedic instrument, the Kirschner Wire must be stored in a clean, dry environment to prevent contamination. Proper sterilization protocols must be followed before reuse to ensure patient safety in sterile surgical settings.