FDA product code PPT: Cranial Surgical Planning And Instrument Guides
PPT is the FDA product code for cranial surgical planning and instrument guides. It is a Class II device, regulated under 21 CFR 882.4310 and reviewed by the Neurology panel. FDA has cleared 4 510(k) submissions under PPT, 1 in the last five years, from 3 different applicants. The average 510(k) review took 254 days (median 208); 100 days on average over the last three years.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Cranial Surgical Planning And Instrument Guides |
| Device class | Class II |
| Regulation | 21 CFR 882.4310 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for PPT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 284 |
| 2020 | 1 | 132 |
| 2026 | 1 | 100 |
Compare with all 510(k) review times · Search every PPT clearance
Top PPT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KLS-Martin L.P. | 2 | 2020-08-31 |
| Materialise NV | 1 | 2026-01-07 |
| 3D Systems, Inc. | 1 | 2016-09-23 |
Most recent PPT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253308 | Materialise NV | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | 2026-01-07 | 100 |
| K201052 | KLS-Martin L.P. | KLS Martin Individual Patient Solutions (IPS) Planning System | 2020-08-31 | 132 |
| K182889 | KLS-Martin L.P. | KLS Martin Individual Patient Solutions (IPS) Planning System | 2019-07-26 | 284 |
| K151285 | 3D Systems, Inc. | VSP Cranial System | 2016-09-23 | 498 |
Recalls for PPT devices
openFDA lists no recalls for product code PPT.
Frequently asked questions
What is FDA product code PPT?
PPT is the FDA product code for cranial surgical planning and instrument guides. It is a Class II device, regulated under 21 CFR 882.4310 and reviewed by the Neurology panel.
What device class is PPT?
Class II, regulation 21 CFR 882.4310. Typical premarket route: 510(k).
How long does a 510(k) take for product code PPT?
Across 4 cleared submissions the average was 254 days from receipt to decision (median 208).
Which companies have the most PPT clearances?
KLS-Martin L.P. (2); Materialise NV (1); 3D Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PPT
- Run a recall and safety report across every PPT manufacturer
- Watch product code PPT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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