# K231860: TDM Screw System

- Pathway: 510(k) (Special)
- Applicant: Tdm Co., Ltd.
- Decided: Jan 18, 2024 after 209 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: 13 generations back to K962616 (1996). 142 ancestors in all.
No later device cites it as a predicate yet.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190830: TDM Screw Systems, Tdm Co., Ltd. (2019) Summary page 5.

## 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 or small and large bones. 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 and fixation of intra-articular fractures of the humerus, femur and tibia. Limited Sliding Screw System: The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur.

Source page: https://510kreport.com/device/K231860
Methodology: https://510kreport.com/methodology