# K230690: Tandry Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Microware Precision Co., Ltd.
- Decided: Aug 17, 2023 after 157 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: 4 generations back to K983495 (1998). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171904: Tandry Locking Plate System, Microware Precision Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K242814: Tandry Q-Locking Plate System (2024), 0 descendants of its own

## Indications for use
The Tandry Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia. In addition, the Tandry Locking Hip Plate System is indicated for 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 for 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/K230690
Methodology: https://510kreport.com/methodology