# K242814: Tandry Q-Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Microware Precision Co., Ltd.
- Decided: Nov 14, 2024 after 57 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: 11 generations back to K962616 (1996). 106 ancestors in all.
No later device cites it as a predicate yet.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230690: Tandry Locking Plate System, Microware Precision Co., Ltd. (2023) Summary page 5.
- K171904: Tandry Locking Plate System, Microware Precision Co., Ltd. (2018) Summary page 5.
- K141527: Depuy Synthes Variable Angle Locking Hand System, Synthes USA (2015) Summary page 5.

## Indications for use
The Tandry Q-Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Q-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. Each plate is indicated for the following anatomic regions: - 1.5mm and 2.0mm Q-locking plates: Metacarpals, metatarsals, tarsals, and phalanges - 2.4mm Q-locking plates: Radius, wrist, and ulna - 3.5 mm Q-locking plates: Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneus, and tibia - 5.0 mm Q-locking plates: Femur and tibia

Source page: https://510kreport.com/device/K242814
Methodology: https://510kreport.com/methodology