# K220360: Tandry CMF Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Microware Precision Co., Ltd.
- Decided: Nov 10, 2022 after 275 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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 K954385 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022185: Universal CMF System, Stryker Instruments (2002) Summary page 4.

## Indications for use
The Tandry CMF System is a Maxillofacial plate and screw system intended for osteotomy, stabilization and rigid fixation of maxillofacial/midface fractures and reconstruction including infraorbital area, zygomatic area and maxillofacial, and mandibular and maxillary correction surgery. Each plate is indicated to be used in the following anatomic regions: • 1.2mm upper-face plates – Orbital floor region, zygomatic region, and dento-alveolar region • 1.5mm mid-face plates – Zygomatic region, orbital floor region, and maxilla • 2.0 mm mini plates – Orthognathics midface/mandible • 2.0/2.3mm mandible plates – Mandibular

Source page: https://510kreport.com/device/K220360
Methodology: https://510kreport.com/methodology