# K190391: TDM Plate and Screw Systems

- Pathway: 510(k) (Traditional)
- Applicant: Tdm Co., Ltd.
- Decided: Nov 15, 2019 after 269 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: 13 generations back to K962616 (1996). 218 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171808: TDM Plate and Screw System, Tdm Co., Ltd. (2018) Summary page 4.
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 4.
- K050110: Synthes (Usa) LCP Modular Foot Plates, Synthes (Usa) (2005) Summary page 4.
- K060514: Stryker Plating System, Howmedica Osteonics Corp. (2006) Summary page 4.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 4.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 4.
- K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 4.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 4.
- K083213: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 4.
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 4.
- K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates, Synthes (Usa) (2010) Summary page 5.
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System, Synthes (USA) Products, LLC (2012) Summary page 5.
- K120854: Synthes VA LCP Ankle Trauma System, Synthes USA (2012) Summary page 5.
- K141735: Arthrex Ankle Fusion Plating System, Arthrex, Inc. (2014) Summary page 5.
- K150099: Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws), Synthes (USA) Products, LLC (2015) Summary page 5.
- K163293: Colink™ Plating System, In2bones USA, LLC (2017) Summary page 5.
- K180310: DePuy Synthes Trauma Orthopedic Plates and Screws, Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. (2018) Summary page 5.

## Most influential descendants
- K241128: TDM Plate and Screw System (2024), 0 descendants of its own

## Indications for use
Mini and Mid Locking Plate and Screw System: The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot. Small Locking Plate and Screw System: The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula. The TDM Screws (1.5mm and larger, solid) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

Source page: https://510kreport.com/device/K190391
Methodology: https://510kreport.com/methodology