# K253308: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models

- Pathway: 510(k) (Special)
- Applicant: Materialise NV
- Decided: Jan 7, 2026 after 100 days
- Product code: PPT (Cranial Surgical Planning And Instrument Guides)
- Device class: 2
- Regulation: 21 CFR 882.4310
- 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 K924630 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243637: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery, Materialise NV (2025) Summary page 6.

## Indications for use
CMF Titanium Guides CMF Titanium Guides are intended to guide the marking of bone and/or guide surgical instruments in craniofacial 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 craniomaxillofacial surgery. CMF Plastic Models CMF Plastic Models 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 craniofacial 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 craniomaxillofacial surgery.

Source page: https://510kreport.com/device/K253308
Methodology: https://510kreport.com/methodology