# K190830: TDM Screw Systems

- Pathway: 510(k) (Traditional)
- Applicant: Tdm Co., Ltd.
- Decided: Sep 13, 2019 after 165 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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). 141 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw, Synthes USA Products, LLC (2017) Summary page 4.
- K123890: Acumed Cannulated Screw System, Acumed, LLC (2013) Summary page 4.
- K021556: Synthes 2.4 MM Cannulated Compression Screw, Synthes (Usa) (2002) Summary page 4.
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 4.
- K080943: Synthes 4.5 MM and 6.5 MM Headless Compression Screws, Synthes (Usa) (2008) Summary page 4.
- K063020: Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System, Intai Technology, Inc. (2006) Summary page 4.

## Most influential descendants
- K231860: TDM Screw System (2024), 0 descendants of its own

## Indications for use
The TDM Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device. Cannulated Screw System: The Cannulated Screw System is intended to be used for fracture of small bones of the hand or foot (2.5mm) or small and large bones (4.0mm larger). Headless Compression Cannulated Screw System: The Headless Compression Cannulated Screw System is intended to be used for a wide range of different indications in the hand, wrist and joint fusion (arthrodeses) in the foot (2.3mm & 3.5mm, 3.0mm & 4.0mm) and fixation of intra-articular fractures of the humerus, femur and tibia (3.5mm & 5.0mm). Limited Sliding Screw System: The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur, large bones and large bone fragments.

Source page: https://510kreport.com/device/K190830
Methodology: https://510kreport.com/methodology