Cleared Traditional

K190523 - Cranial PSI Accessory ? Anatomical Model Original, Cranial PSI Accessory ? Anatomical Model Modified, Cranial PSI Accessory ? Plastic Drawing Guide, Cranial PSI Accessory ? Cranial Implant Trial
(FDA 510(k) Clearance)

K190523 · Ossdsign AB · Neurology device
Oct 2019
Decision
220d
Days
Class 2
Risk

K190523 is an FDA 510(k) clearance for the Cranial PSI Accessory ? Anatomical Model Original, Cranial PSI Accessory ? Anatomical Model Modified, Cranial PSI Accessory ? Plastic Drawing Guide, Cranial PSI Accessory ? Cranial Implant Trial. This device is classified as a Filler, Bone Void, Non-alterable Compound For Cranioplasty (Class II - Special Controls, product code PJN).

Submitted by Ossdsign AB (Uppsala, SE). The FDA issued a Cleared decision on October 10, 2019, 220 days after receiving the submission on March 4, 2019.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5330. A Nonalterable Cranial Bone Void Filler Is A Device That Is Created From Patient-specific Computerized Tomography (ct) Imaging Data And Intended To Fill Bony Voids, Defects, And Contour Irregularities In Non-load Bearing Regions Of The Cranial Skeleton, And Are Not Intrinsic To The Stability Of The Bony Structure. The Materials Used (e.g., Metals, Polyether Ether Ketone (peek), Etc.) In The Construction Of The Nonalterable Cranial Bone Void Fillers Are Not Resorbable And Cannot Be Altered Or Reshaped At The Time Of Surgery Or After Implantation Without Changing The Chemical Behavior Of The Material..

Submission Details

510(k) Number K190523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date October 10, 2019
Days to Decision 220 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code PJN — Filler, Bone Void, Non-alterable Compound For Cranioplasty
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.5330
Definition A Nonalterable Cranial Bone Void Filler Is A Device That Is Created From Patient-specific Computerized Tomography (ct) Imaging Data And Intended To Fill Bony Voids, Defects, And Contour Irregularities In Non-load Bearing Regions Of The Cranial Skeleton, And Are Not Intrinsic To The Stability Of The Bony Structure. The Materials Used (e.g., Metals, Polyether Ether Ketone (peek), Etc.) In The Construction Of The Nonalterable Cranial Bone Void Fillers Are Not Resorbable And Cannot Be Altered Or Reshaped At The Time Of Surgery Or After Implantation Without Changing The Chemical Behavior Of The Material.