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Steinman Pin

by O'Tec Corp. 510(k)

Active United States

510(k) K905337

Overview

A Steinman pin is an orthopedic device used for skeletal traction and fixation of bone fractures. It is a metallic pin designed to be inserted into bone to provide stable alignment and support during healing.

The device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the healthcare facility. It is indicated for use in orthopedic procedures and has received FDA 510(k) clearance under product code HTY, with clearance granted on December 11, 1990.

AI-generated from registry data, 23 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 NumberK905337 Date11 Dec 1990ClearedStatusActive

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 Steinman pin used for?

    The Steinman pin is an orthopedic device used for skeletal traction and fixation of bone fractures, providing stable alignment and support during healing by being inserted into bone.

  • How is the Steinman pin supplied and prepared for use?

    The device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the healthcare facility prior to each procedure.

  • Is the Steinman pin designed for single-use or reuse?

    The Steinman pin is intended for reusable use, meaning it can be used multiple times after proper cleaning and sterilization by the healthcare facility between uses.

  • What regulatory pathway was used for the Steinman pin?

    The Steinman pin received FDA 510(k) clearance under product code HTY, with a traditional clearance granted on December 11, 1990, based on substantial equivalence to a predicate device.