Cleared Traditional

K212414 - OSSDSIGN Cranial PSI (FDA 510(k) Clearance)

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

K212414 · Ossdsign AB · Neurology device
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Oct 2021
Decision
59d
Days
Class 2
Risk

K212414 is an FDA 510(k) clearance for the OSSDSIGN Cranial PSI. 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 1, 2021 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ossdsign AB devices

Submission Details

510(k) Number K212414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2021
Decision Date October 01, 2021
Days to Decision 59 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 148d · This submission: 59d
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.

Regulatory Consultant

David Weissburg
David Weissburg

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.