Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (K243637)
Description
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery by Materialise N.V, an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243637
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (K243637) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2022 |
| K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2019 |
| K173039 | TruMatch CMF Titanium 3D Printed Implant | Materialise NV | 2018 |
| K170272 | TruMatch CMF Titanium 3D Printed Implant System | Materialise NV | 2017 |
| K111558 | SURGICASE GUIDE | Materialise NV | 2012 |
| K103136 | SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE | Materialise NV | 2011 |
Trace the full predicate network for K243637
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.