Ortho Solutions Ultos Plating System

• • Ongoing Z-0230-2026 FDA Class II ·initiated 17 Sep 2025

  Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.

• • Terminated Z-0026-2016 FDA Class II ·initiated 14 Jul 2015 ·on shared 510(k) K141784

  Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ

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

510(k) Number

K141784 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Ortho Solutions Trauma Implants for Osteosynthesis

  Class II

  FDA 510(k) K110895 Active Cleared 19 Dec 2011

• Ortho Solutions Trauma Plates for Osteosysnthesis

  Class II

  FDA 510(k) K120360 Active Cleared 29 May 2012

• Oxford Ankle Fusion Nail(Afn) System

  Class II

  FDA 510(k) K121575 Active Cleared 14 Sep 2012

• Ortho Solutions Extremity Fixation Implants for Osteosysnthesis

  Class II

  FDA 510(k) K111678 Active Cleared 7 Feb 2012

• Ortho Solutions - Sterile, Drills, Taps, Guide Pins & Wires

  Class I

  FDA 510(k) K102743 Active Cleared 20 Jan 2011