Synthes External Fixation Component Line Extension MR Safe

No FDA recalls on record, checked 22 Oct 2026.

Full name

Synthes (USA) External Fixation Component Line Extension - MR Safe

510(k) Number

K043039 ↗

FDA Product Code

KTT

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 is the primary clinical use for these fixation components?

  These components are specifically designed to construct external fixation frames used in the clinical treatment of both stable and unstable bone fractures.

• Are these components compatible with magnetic resonance imaging?

  Yes, the system is classified as MR Safe. All frame elements, including the pin clamps and curved carbon fiber rods, are constructed from non-magnetic materials to ensure safety within the MR environment.

• What specific items are included in this component line extension?

  The line extension consists of pin clamps equipped with outrigger posts and curved carbon fiber rods, which allow for the assembly of customized external fixation frames.

• What is the regulatory status of this device?

  This device has received FDA 510k clearance, under K-number K043039, for use in the construction of external fixation frames for various types of fractures.