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)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190523 · Ossdsign AB · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 – An.... Classified as Filler, Bone Void, Non-alterable Compound For Cranioplasty (product code PJN), Class II - Special Controls.

Submitted by Ossdsign AB (Uppsala, SE). The FDA issued a Cleared decision on October 10, 2019 after a review of 220 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ossdsign AB devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 148d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PJN Filler, Bone Void, Non-alterable Compound For Cranioplasty
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.