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Cranial PSI Accessory – Anatomical (Original +3 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K190523

by Ossdsign AB

Identifiers

510(k) Number
K190523 FDA 510(k)
FDA Product Code
PJN FDA 510(k)
Models / Variants
Original FDA 510(k)
Cranial PSI Accessory – Anatomical Model Modified FDA 510(k)
Cranial PSI Accessory – Plastic Drawing Guide FDA 510(k)
Cranial PSI Accessory – Cranial Implant Trial FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5330 FDA 510(k)
Regulation Number
882.5330 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cranial PSI Accessories are patient-specific, non-alterable anatomical tools designed for cranioplasty procedures. These include anatomical models (original and modified), a plastic drawing guide for marking bone resection sites, and a cranial implant trial for verifying implant fit. They are classified as filler, bone void, non-alterable compounds for cranioplasty under FDA regulation 882.5330 and fall under device class II.

These accessories are supplied non-sterile and are not intended for sterilization. They are intended for use in neurosurgical settings to assist in preoperative planning and intraoperative orientation, with the anatomical models providing visual and tactile guidance for physicians. The plastic drawing guide aids in marking bone removal areas, while the cranial implant trial ensures proper implant fit before final placement. The suite is authorized under FDA 510(k) clearance (K190523) and is intended for single-use applications.

Frequently asked questions

Are these accessories meant to be reused in multiple procedures, or are they designed for single-use only?

The Cranial PSI Accessories are explicitly designed for single-use applications only. This includes the anatomical models (original and modified), the plastic drawing guide, and the cranial implant trial. Since they are classified as non-sterile and not intended for sterilization, reuse could compromise patient safety and accuracy, making single-use the recommended practice.

How do these tools assist in preoperative planning and intraoperative orientation during cranioplasty?

The anatomical models (original and modified) provide visual and tactile guidance for surgeons, allowing them to study the patient’s specific cranial anatomy before and during surgery. The plastic drawing guide helps mark precise bone resection sites, ensuring accurate preparation, while the cranial implant trial verifies the fit of the implant beforehand, reducing intraoperative adjustments and improving procedural confidence.

What is the intended clinical setting for using these accessories, and why?

These accessories are intended for use in neurosurgical settings, specifically for cranioplasty procedures. Their design supports preoperative planning (via anatomical models) and intraoperative orientation (via the drawing guide and implant trial), which are critical in neurosurgery to ensure precision, reduce complications, and enhance surgical outcomes.

Why are these tools supplied non-sterile, and can they be sterilized if needed?

The Cranial PSI Accessories are supplied non-sterile because they are not intended for direct implantation or contact with sterile surgical fields in a way that would require sterilization. The manufacturer explicitly states they are not intended for sterilization, meaning they should not be subjected to sterilization processes like autoclaving or ethylene oxide treatment, as this could alter their structural integrity or intended use.

What distinguishes the ‘Original’ and ‘Modified’ anatomical models, and how might a surgeon choose between them?

The Original and Modified anatomical models are patient-specific tools tailored to individual cranial anatomies. The ‘Modified’ version likely accounts for adjustments based on preoperative imaging or surgical planning changes, such as bone resection variations or implant adjustments. A surgeon would choose between them based on the specific anatomical requirements of the patient’s case, ensuring the model accurately reflects the planned cranioplasty procedure.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cranial PSI Accessory - Anatomical Model Original, Cranial PSI ..., Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory ..., Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ossdsign AB

Sources (1)

  • FDA 510(k) K190523 24 fields · synced Oct 6, 2026