# K202764: Ortho Solutions Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Solutions UK, Ltd.
- Decided: Nov 20, 2020 after 60 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K962616 (1996). 182 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120360: Ortho Solutions Trauma Plates for Osteosysnthesis, Ortho Solutions Limited (2012) Summary page 5.
- K141784: Ortho Solutions Ultos Plating System, Ortho Solutions Limited (2014) Summary page 5.
- K163044: ORTHOLOC® 3Di Ankle Fracture Plating System, Wrightmedicaltechnologyinc (2017) Summary page 5.

## Most influential descendants
- K210658: Volition Plating System (2021), 0 descendants of its own

## Indications for use
The Ortho Solutions Plating System is indicated for use in stabilization and fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists. In addition, the non-locking screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Source page: https://510kreport.com/device/K202764
Methodology: https://510kreport.com/methodology