Synthes Tibial Nail System EX

• • Terminated Z-2051-2015 FDA Class II ·initiated 3 Jun 2015

  A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.

• • Terminated Z-2058-2013 FDA Class II ·initiated 2 Nov 2012 ·on shared 510(k) K040762

  Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

Synthes (USA) Tibial Nail System Ex

510(k) Number

K040762 ↗

FDA Product Code

JDS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Synthes Light Guide

  Class II

  FDA 510(k) K993314 Active Cleared 6 Dec 1999

• Synthes Locking Hand Plates

  Class II

  FDA 510(k) K092247 Active Cleared 25 Sep 2009

• Synthes Matrix Mis Rods

  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

• Synthes Lcp Proximal Tibia Plate

  Class II

  FDA 510(k) K011978 Active Cleared 9 Aug 2001

• Synthes Locking Calcaneal Plates

  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

See all devices from Synthes (Usa) →

• What types of tibial fractures is this system designed to stabilize, and how does it achieve stability?

  The Synthes Tibial Nail System EX is designed for stabilizing tibial fractures by providing axial compression and rotational stability through its cannulated tibial nails, 5.0 mm dual-core locking screws, and end caps. The system accommodates various fracture patterns due to its modular nail sizes and screw configurations, ensuring secure fixation for different clinical scenarios.

• Is this device intended for reuse, or is it meant to be used only once per patient?

  The Synthes Tibial Nail System EX is explicitly intended for single-use only, requiring sterile handling to ensure patient safety and device efficacy. This aligns with standard orthopedic practices for intramedullary fixation devices to prevent cross-contamination and maintain sterility.

• What range of nail sizes and screw configurations are available, and how do they help in treatment?

  The system offers multiple nail sizes and screw configurations to match different fracture patterns and anatomical requirements. While exact measurements aren’t specified, the modular design allows for customization to fit varying tibial lengths and fracture complexities, ensuring optimal stability and alignment during healing.

• How should this device be stored to maintain its integrity before use?

  Since the Synthes Tibial Nail System EX is sterile and intended for single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures sterility and prevents damage to the components before surgical use.

• What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?

  The device holds an FDA 510(k) clearance under the traditional review pathway, classified as a Class II medical device with special controls for orthopedic applications. This means it was deemed substantially equivalent to a legally marketed predicate device, allowing its use in clinical and operating room settings for tibial fracture stabilization as described.