# K171808: TDM Plate and Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Tdm Co., Ltd.
- Decided: Mar 15, 2018 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: 12 generations back to K000684 (2000). 95 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123241: Arthrex Fracture Plates, Arthrex, Inc. (2013) Summary page 4.
- K141478: Arthrex Fracture Plates and Screws, Arthrex, Inc. (2014) Summary page 4.
- K151732: Arthrex Fracture Plates, Arthrex, Inc. (2015) Summary page 4.
- K141735: Arthrex Ankle Fusion Plating System, Arthrex, Inc. (2014) Summary page 4.
- K132898: A.L.P.S. Calcaneal Plating System, Biomet Manufacturing Corp (2013) Summary page 4.
- K030198: Hand Innovations, Inc. Distal Radius Fracture Repair System, Hand Innovations, Inc. (2003) Summary page 4.
- K020401: Synthes Calcaneal Plate, Synthes (Usa) (2002) Summary page 4.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006) Summary page 4.
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 4.

## Most influential descendants
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K190391: TDM Plate and Screw Systems (2019), 1 descendant of its own
- K261830: FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) (2026), 0 descendants of its own
- K260277: Mikron Trauma Bone Plate& Screw System (2026), 0 descendants of its own
- 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, calcaneous, fibula and other small bones. 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, calcaneous, femur and fibula.

Source page: https://510kreport.com/device/K171808
Methodology: https://510kreport.com/methodology