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Intramedullary Systems

by Baumer Ortopedia, Ltd. Brazil 510(k)

510(k) K930972

Product code HSB

Overview

The Intramedullary Systems are orthopedic fixation devices designed as rods, intramedullary and their associated accessories. These systems are intended for internal fixation of long bone fractures, providing stability and alignment during the healing process.

Used in orthopedic surgical settings, these systems are classified as reusable medical devices under FDA regulation 888.3020. They are supplied sterile and are regulated under a Traditional 510(k) clearance (K930972) with a decision of Substantially Equivalent (SESE), approved on March 29, 1994. The product code assigned is HSB, and the device falls under the Orthopedic specialty classification.

Summary written by AI from registry data, 19 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK930972 Date29 Mar 1994ClearedStatusActive

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 America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
HSB
FDA applicant
Baumer Ortopedia , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Baumer Ortopedia, Ltd.

  • Baumer Plates

    Class II

  • Baumer Staples

    Class II

  • Baumer Pins

    Class II

  • Baumer Screws

    Class II

Questions

  • Are these intramedullary systems intended for single-use or can they be reused in multiple procedures?

    These intramedullary systems are classified as reusable medical devices under FDA regulation 888.3020. This means they are designed to be sterilized and used in multiple surgical procedures, provided they meet the necessary reprocessing standards for orthopedic fixation devices.

  • How are the intramedullary systems supplied, and are they sterile upon arrival?

    The intramedullary systems are supplied sterile, ensuring they are ready for immediate use in orthopedic surgical settings without additional sterilization steps before implantation.

  • What types of long bone fractures are these systems intended to stabilize, and how do they achieve this?

    While the exact clinical indications are not detailed here, these devices are designed for internal fixation of long bone fractures, providing mechanical stability and proper alignment to facilitate the healing process. They are used in orthopedic surgeries to hold bone fragments together during recovery.

  • What is the regulatory pathway for these intramedullary systems, and when were they cleared by the FDA?

    These intramedullary systems follow the Traditional 510(k) clearance pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. They were cleared by the FDA on March 29, 1994, under the product code HSB, which falls under the Orthopedic specialty classification.

  • Who is the manufacturer of these intramedullary systems, and where are they based?

    The manufacturer of these intramedullary systems is Baumer Ortopedia, Ltd., based at Av. Prefeito Antonio Tavares Leite 381, Mogi Mirim-SP, Brazil. For inquiries, you may contact Paulo S Ivo at the provided address.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K930972 24 fields · synced 22 Oct 2026