# K171904: Tandry Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Microware Precision Co., Ltd.
- Decided: Sep 18, 2018 after 449 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: 3 generations back to K983495 (1998). 11 ancestors in all.
11 later devices descend from it; 7 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072562: Microware Bone Plates and Bone Screws, Microware Precision Co., Ltd. (2008) Summary page 4.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 4.
- K023802: Synthes 4.5 MM Titanium LCP Proximal Tibia Plating System, Synthes (Usa) (2003) Summary page 4.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 4.
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 4.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, 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
- K202971: DRPx Locking Distal Radius Plate System (2021), 2 descendants of its own
- K230690: Tandry Locking Plate System (2023), 1 descendant of its own
- K223118: OIC Variable Angle Small Fragment Locking Plate System (2023), 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

## Indications for use
Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies for bones including the clavicle, pelvis, scapula and calcaneal, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges; long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia. In addition, Tandry Locking Hip Plate System is intended for use in fixation of fractures to the proximal femur. The plates are indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fracture. Each plate is indicated to be used in the following anatomic regions: • 1.5mm and 2.0mm locking plates – Metacarpals, metatarsals, tarsals, and phalanges • 2.4mm locking plates – Radius, wrist, and ulna • 3.5 mm locking plates – Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneal, and tibia • 5.0 mm locking plates – Femur and tibia

Source page: https://510kreport.com/device/K171904
Methodology: https://510kreport.com/methodology