# K141784: Ortho Solutions Ultos Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Solutions Limited
- Decided: Jul 23, 2014 after 21 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962616 (1996). 136 ancestors in all.
28 later devices descend from it; 4 cite it directly.
0 of 165 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis, Ortho Solutions Limited (2012) Summary page 1.
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 1.
- K100359: Darco Headed Cannulated Screw, Wrightmedicaltechnologyinc (2010) Summary page 1.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 1.

## Most influential descendants
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own
- K193222: Tyber Medical Anatomical Plating System (2020), 11 descendants of its own
- K203817: Tyber Medical Anatomical Plating System (2021), 10 descendants of its own
- K222465: Tyber Medical Anatomical Plating System (2023), 9 descendants of its own
- K183011: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (2019), 5 descendants of its own

## Recalls of this device
- Sep 17, 2025 · Class II · Z-0230-2026: 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)
- Jul 14, 2015 · Class II · Z-0026-2016: 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 

## Indications for use
The intended use of the Ortho Solutions UltOS Plating System fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing. The Ortho Solutions UltOS Plating System is indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the feet, ankles, and toes skeleton. This implant should only be used with the Ortho Solutions UltOS Plating System. Combination with other implants or instrumentation is not permissible. The Ortho Solutions UltOS Plating System is not intended for spinal use.

Source page: https://510kreport.com/device/K141784
Methodology: https://510kreport.com/methodology