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DePuy Synthes TFNA Augmentation System

by Synthes (USA) Products, LLC 510(k)

Active United States

510(k) K160167

Overview

The DePuy Synthes TFNA Augmentation System is an advanced fixation system for proximal femur fractures in adults and adolescents. It is intended for treatment of fractures in patients with poor bone quality, such as osteoporosis, through augmentation of the TFN-ADVANCED Proximal Femoral Nailing System.

This system is supplied as part of the TFN-ADVANCED Proximal Femoral Nailing System and is used with cannulated implants and instruments. It is regulated under FDA 510K clearance with product code HSB and is manufactured by Synthes (USA) Products, LLC.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160167 Date26 Sep 2016ClearedStatusActive

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

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1239-2024 FDA Class II initiated 24 Jan 2024
    • Ongoing Z-1240-2024 FDA Class II initiated 24 Jan 2024

    Products not sterilized, sterility cannot be confirmed

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 Synthes (USA) Products LLC

See all devices from Synthes (USA) Products LLC →

Questions

  • What is the DePuy Synthes TFNA Augmentation System used for?

    The TFNA Augmentation System is designed for treating proximal femur fractures in adults and adolescents with poor bone quality, such as osteoporosis. It works by augmenting the TFN-ADVANCED Proximal Femoral Nailing System to provide additional fixation stability.

  • How is the TFNA Augmentation System supplied?

    The system is supplied as part of the TFN-ADVANCED Proximal Femoral Nailing System and includes cannulated implants and instruments necessary for the augmentation procedure. It is manufactured by Synthes (USA) Products, LLC.

  • Is the TFNA Augmentation System single-use or reusable?

    The device information does not specify whether the TFNA Augmentation System is single-use or reusable. Clinicians should refer to the product's instructions for use or contact the manufacturer for clarification on reprocessing and reuse protocols.

  • What regulatory approval does the TFNA Augmentation System have?

    The DePuy Synthes TFNA Augmentation System has received FDA 510K clearance with product code HSB. It was determined to be substantially equivalent to predicate devices and is regulated under this clearance pathway.