# K220359: Tandry Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Microware Precision Co., Ltd.
- Decided: Sep 20, 2022 after 224 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: 8 generations back to K962823 (1996). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133460: Aptus Cannulated Compression Screws, Medartis AG (2013) Summary page 4.
- K171904: Tandry Locking Plate System, Microware Precision Co., Ltd. (2018) Summary page 4.

## Indications for use
Tandry Compression Screw System is intended for the treatment of fractures, osteotomies, and fusions of bone with the appropriate screw size.

Source page: https://510kreport.com/device/K220359
Methodology: https://510kreport.com/methodology