PPT · Class II · 21 CFR 882.4310

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 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
1–4 of 4
Cleared Jan 07, 2026
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides
K253308
Materialise NV
Neurology · 100d

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 Review Time

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 →