# K170272: TruMatch CMF Titanium 3D Printed Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Aug 8, 2017 after 190 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063790 (2007). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083388: Synthes Matrixorthognathis Fixation System, Synthes (Usa) (2009) Summary page 5.
- K063790: The Synthes Matrixmandible Plate and Screw System, Synthes (Usa) (2007) Summary page 6.
- K080331: Synthes Craniofacial Plate and Screw System, Synthes (Usa) (2008) Summary page 6.

## Most influential descendants
- K173039: TruMatch CMF Titanium 3D Printed Implant (2018), 2 descendants of its own
- K182305: Stryker Facial iD Plating System (2019), 1 descendant of its own
- K233874: tmCMF Solution (2024), 0 descendants of its own
- K232889: METICULY Patient-specific titanium maxillofacial mesh implant (2024), 0 descendants of its own
- K193143: Stryker Facial iD Plating System (2020), 0 descendants of its own

## Recalls of this device
- Feb 3, 2020 · Class II · Z-1485-2020: Custom surgical kits contain a plate different than indicated by the package labeling.
- Feb 3, 2020 · Class II · Z-1484-2020: Custom surgical kits contain a plate different than indicated by the package labeling.

## Indications for use
The TruMatch CMF Titanium 3D Printed Implant System is intended for bone repositioning, fixation and reconstruction of the maxillofacial skeleton, midface, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific indications for use: • Orthognathic surgery. • Reconstructive mandible and maxillofacial surgery. • Mandible and maxillofacial trauma surgery.

Source page: https://510kreport.com/device/K170272
Methodology: https://510kreport.com/methodology