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Flex-Thread Ulna Intramedullary Nail System

by FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower 510(k)

Active United States

510(k) K222390

Overview

The Flex-Thread Ulna Intramedullary Nail System is a device used for the treatment and fixation of fractures and osteotomies of the ulna. It provides fracture reduction to restore anatomical relationships and offers fracture fixation with absolute or relative stability while preserving blood supply.

The system is supplied as part of the Flex-Thread technology platform and has received FDA 510(k) clearance with the K222390 number. It is intended for use in the ulna bone, with various sizes available to accommodate different anatomical requirements. The device is designed to be used in a clinical setting for fracture management.

AI-generated from registry data, 26 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 NumberK222390 Date21 Nov 2022ClearedStatusActive

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 25 Oct 2026.

Specification

510(k)

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

Other devices from FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower

Questions

  • What is the Flex-Thread Ulna Intramedullary Nail System used for?

    The Flex-Thread Ulna Intramedullary Nail System is designed for the treatment and fixation of fractures and osteotomies of the ulna. It helps restore anatomical relationships through fracture reduction and provides fixation with absolute or relative stability while preserving blood supply.

  • What sizes are available for the Flex-Thread Ulna Intramedullary Nail System?

    The Flex-Thread Ulna Intramedullary Nail System is available in various sizes to accommodate different anatomical requirements of the ulna bone. This range ensures appropriate sizing for different patients and clinical situations.

  • What is the regulatory status of the Flex-Thread Ulna Intramedullary Nail System?

    The Flex-Thread Ulna Intramedullary Nail System has received FDA 510(k) clearance with the K222390 number. It is classified under product code HSB and was determined to be substantially equivalent to predicate devices.

  • How is the Flex-Thread Ulna Intramedullary Nail System supplied?

    The Flex-Thread Ulna Intramedullary Nail System is supplied as part of the Flex-Thread technology platform. It is designed for use in clinical settings for fracture management of the ulna bone.