# K241128: TDM Plate and Screw System

- Pathway: 510(k) (Special)
- Applicant: Tdm Co., Ltd.
- Decided: Dec 5, 2024 after 225 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: 14 generations back to K962616 (1996). 219 ancestors in all.
No later device cites it as a predicate yet.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190391: TDM Plate and Screw Systems, Tdm Co., Ltd. (2019) Summary page 6.
- K171808: TDM Plate and Screw System, Tdm Co., Ltd. (2018) Summary page 6.

## Indications for use
The TDM Plate and Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device. 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 and Cannulated) 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/K241128
Methodology: https://510kreport.com/methodology