Cleared Traditional

K133082 - OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE

K133082 is an FDA 510(k) clearance for OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIA..., manufactured by Osteosymbionics, LLC. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K133082 · Osteosymbionics, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
232d
Days
Class 2
Risk

K133082 is an FDA 510(k) clearance for the OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Osteosymbionics, LLC (Cleveland, US). The FDA issued a Cleared decision on May 20, 2014 after a review of 232 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.

FDA 510(k) Submission Details - K133082

510(k) Number K133082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date May 20, 2014
Days to Decision 232 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
83d slower than avg
Panel avg: 149d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXN Device Classification - Class 2, Special Controls

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 56
Devices cleared under the same product code (GXN) and FDA review panel - the closest regulatory comparables to K133082.
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K121818 · Oxford Performance Materials · Feb 2013
CUSTOM CRANIOFACIAL IMPLANT (CCI)
K121755 · Kelyniam Global, Inc. · Sep 2012
CRAINFIX 2 TITANIUM CLAMP SYSTEM
K122353 · Aesculap, Inc. · Aug 2012
K133082 · OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
Download PDF FDA Summary Osteosymbionics, LLC