Cleared Traditional

Cranial PSI (K161090) - FDA 510(k) Clearance

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

K161090 · Ossdsign AB · Neurology device
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Optimized for regulatory review, auditing and printing
Jan 2017
Decision
276d
Days
Class 2
Risk

K161090 is an FDA 510(k) clearance for the Cranial PSI. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Ossdsign AB (Uppsala, SE). The FDA issued a Cleared decision on January 19, 2017 after a review of 276 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 K161090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2016
Decision Date January 19, 2017
Days to Decision 276 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
128d slower than avg
Panel avg: 148d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
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 Peers - GXN Plate, Cranioplasty, Preformed, Non-alterable

All 25
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K161090.
OsteoFab Patient Specific Cranial Device
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Longeviti PMMA Static Cranial Implant
K170410 · Longeviti Neuro Solutions, LLC · Mar 2018
CRAINFIX 2 TITANIUM CLAMP SYSTEM
K122353 · Aesculap, Inc. · Aug 2012
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K053199 · Synthes (Usa) · Dec 2005
SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
K033868 · Synthes (Usa) · Jun 2004