# K243637: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Feb 21, 2025 after 88 days
- Product code: DZJ (Driver, Wire, And Bone Drill, Manual)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924630 (1993). 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)
- K182789: KLS Martin Individual Patient Solutions (IPS) Planning System, KLS-Martin L.P. (2019) Summary page 6.

## Most influential descendants
- K253308: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (2026), 0 descendants of its own

## Indications for use
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery Materialise Personalized Guides for Craniomaxillofacial Surgery Materialise Personalized Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and/or guide surgical instruments in facial surgery. CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications. CMF Titanium Guides are intended for children, adolescents and adults. CMF Titanium Guides are intended for single use only. CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery. Materialise Personalized Models for Craniomaxillofacial Surgery Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures. CMF Plastic Models are intended for infants, children, adolescents and adults. CMF Plastic Models are intended for single use only. CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery.

Source page: https://510kreport.com/device/K243637
Methodology: https://510kreport.com/methodology