Skip to content

DePuy Synthes Tibial Nail Advanced, Locking Screws (4.0 and 5.0mm)

by Synthes (USA) Products, LLC

510(k) K201336

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201336 Date3 Sep 2020ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0229-2026 FDA Class II initiated 26 Sep 2025
    • Ongoing Z-0228-2026 FDA Class II initiated 26 Sep 2025

    Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
510(k) Number
FDA Product Code
JDS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DePuy Synthes Tibial Nail Advanced is an intramedullary nail system designed for the fixation of tibial shaft fractures. It is classified as a bone fixation nail, intended for internal stabilization of long bone fractures, specifically within the tibia. The device incorporates locking screws to secure the nail in place, ensuring stable alignment during the healing process.

This system is supplied sterile and intended for single-use in orthopedic surgical settings. It includes nails ranging from 8 to 13 mm in diameter and locking screws of 4.0 and 5.0 mm, along with reaming rods for preparation. The device has received FDA 510(k) clearance under the traditional pathway, classified as a Class II medical device. It is intended for use in procedures requiring infra-, supra-, or parapatellar approaches.

Other devices from Synthes (USA) Products LLC

See all devices from Synthes (USA) Products LLC →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DePuy Synthes Tibial Nail Advanced used for?

    The DePuy Synthes Tibial Nail Advanced is designed specifically for the internal stabilization of tibial shaft fractures. It provides secure fixation through an intramedullary nail system, which is locked in place with screws to maintain proper alignment during bone healing. This system is intended for orthopedic procedures where stable fixation is critical, such as in complex or displaced fractures.

  • How is the DePuy Synthes Tibial Nail Advanced supplied, and is it sterile?

    The DePuy Synthes Tibial Nail Advanced is supplied sterile and intended for single-use in surgical settings. This ensures infection control and compliance with clinical best practices, as sterile instruments are essential for minimizing postoperative complications in fracture fixation procedures.

  • What nail diameters and locking screw sizes are included in this system?

    The system includes intramedullary nails ranging from 8 to 13 millimeters in diameter, along with locking screws available in 4.0mm and 5.0mm sizes. These variations allow surgeons to select the appropriate dimensions based on patient anatomy and fracture characteristics for optimal fit and stability.

  • Does this device require reaming, and what tools are provided?

    Yes, the DePuy Synthes Tibial Nail Advanced system includes reaming rods, which are used to prepare the medullary canal before nail insertion. Reaming ensures proper sizing and alignment, reducing the risk of complications such as malunion or implant failure during the healing process.

  • What surgical approaches are compatible with this nail system?

    The DePuy Synthes Tibial Nail Advanced is designed for use with infra-, supra-, or parapatellar approaches, providing flexibility in surgical technique depending on the patient’s anatomy and the surgeon’s preference. This versatility accommodates different clinical scenarios while maintaining the device’s intended function for fracture stabilization.