Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4310](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4310) → PPT — Cranial Surgical Planning And Instrument Guides

# PPT · Cranial Surgical Planning And Instrument Guides

_Neurology · 21 CFR 882.4310 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PPT

## Overview

- **Product Code:** PPT
- **Device Name:** Cranial Surgical Planning And Instrument Guides
- **Regulation:** [21 CFR 882.4310](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4310)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253308](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PPT/K253308.md) | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | Materialise NV | Jan 7, 2026 | SESE |
| [K201052](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PPT/K201052.md) | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | Aug 31, 2020 | SESE |
| [K182889](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PPT/K182889.md) | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | Jul 26, 2019 | SESE |
| [K151285](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PPT/K151285.md) | VSP Cranial System | 3D Systems, Inc. | Sep 23, 2016 | SESE |

## Top Applicants

- KLS-Martin L.P. — 2 clearances
- 3D Systems, Inc. — 1 clearance
- Materialise NV — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PPT](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/PPT)

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