# K232115: TDM Large Bone Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Tdm Co., Ltd.
- Decided: Apr 5, 2024 after 266 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: 12 generations back to K962616 (1996). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141796: Depuy Synthes Tomofix Osteotomy System, Synthes (USA) Products, LLC (2014) Summary page 4.
- K112406: Peri-Loc Proximal Femur Locking Bone Plates, Smith & Nephew, Inc. (2011) Summary page 4.
- K210043: LOQTEQ Distal Lateral Femur Plate 4.5 System, Aap Implantate AG (2021) Summary page 4.
- K080522: Synthes 3.5 MM LCP Distal Tibia T Plates, Synthes (Usa) (2008) Summary page 4.
- K202912: ARIX Ankle Distal Tibia System, Jeil Medical Corporation (2020) Summary page 5.
- K213059: Tibia and Fibula System, Auxein Medical Private Limited (2023) Summary page 5.
- K082624: Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates, Synthes (Usa) (2008) Summary page 5.

## Indications for use
The TopFix System is indicated for the fixation of fractures and osteotomies of the distal femur and proximal tibia related to the treatment of bone and joint deformities and / or malalignment caused by injury or disease (e.g., osteoarthritis). The Trifix Large System is indicated for the fixation of fractures (including periprosthetic), non-unions, and malunions of the femur and tibia in adult patients with normal or osteopenic bone. The Newnecks System is indicated for the fixation of fractures of the femoral trochanteric region (e.g., simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with associated medial cortex instability).

Source page: https://510kreport.com/device/K232115
Methodology: https://510kreport.com/methodology