FDA Product Code PPT: Cranial Surgical Planning And Instrument Guides
Software And Hardware For Surgical Planning To Create Patient-specific Anatomical Models, Surgical Templates, And Guides For Use In The Marking Or Cutting Of Cranial Bone For Neurosurgical Procedures.
Leading manufacturers include KLS-Martin L.P. and Materialise NV.
4
Total
4
Cleared
254d
Avg days
2016
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
100d
recently vs 305d historically
FDA 510(k) Cleared Cranial Surgical Planning And Instrument Guides Devices (Product Code PPT)
4 devices
Cleared
Jan 07, 2026
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides
Materialise NV
Neurology
100d
Cleared
Aug 31, 2020
KLS Martin Individual Patient Solutions (IPS) Planning System
KLS-Martin L.P.
Neurology
132d
Cleared
Jul 26, 2019
KLS Martin Individual Patient Solutions (IPS) Planning System
KLS-Martin L.P.
Neurology
284d
About Product Code PPT - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PPT since 2016, with 4 receiving FDA clearance (average review time: 254 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PPT Product Code
Recent submissions under PPT have taken an average of 100 days to reach a decision - down from 305 days historically, suggesting improved FDA processing for this classification.
PPT devices are reviewed by the Neurology panel. Browse all Neurology devices →