Product Code: GXN FDA class 2 21 CFR 882.5330

Plate, Cranioplasty, Preformed, Non-Alterable

Neurology

The Preformed Non-Alterable Cranioplasty Plate is an implanted neurosurgical device used to reconstruct skull defects resulting from trauma, surgery, or disease, providing structural protection to the underlying brain. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant due to its placement within or on the skull. The product code is GXN under regulation 21 CFR 882.5330 in the Neurology specialty. The implant flag is active for this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: GXN
Device Class: FDA class 2
Regulation Number: 882.5330
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253116	3D MAC Titanium Cranial Plate (TCP) System	Jun 18, 2026	Substantially Equivalent	The Surgeon General, Department of the Army (TSG-DA)
K252251	EASYMADE-TI	Apr 09, 2026	Substantially Equivalent	CG Bio Co., Ltd.
K252958	METICULY Patient-specific titanium mesh implant	Jan 14, 2026	Substantially Equivalent	Meticuly Co., Ltd.
K243715	Synthes Patient Specific Implants	Nov 12, 2025	Substantially Equivalent	Synthes GmbH
K252573	KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE	Nov 10, 2025	Substantially Equivalent	KLS-Martin L.P.
K240567	CustomizedBone Service	Mar 28, 2024	Substantially Equivalent	Fin-Ceramica Faenza S.P.A.
K231920	Longeviti ClearFit OTS Cranial Implant	Nov 09, 2023	Substantially Equivalent	Longeviti Neuro Solutions, LLC
K214109	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	Oct 28, 2022	Substantially Equivalent	Kontour(XiAn) Medical Technology Co., Ltd.
K220357	MedCAD AccuShape Titanium Patient-Specific Cranial Implant	Aug 26, 2022	Substantially Equivalent	Medcad
K210099	Meticuly Patient-Specific Titanium Mesh Implant	Dec 21, 2021	Substantially Equivalent	Meticuly Co., Ltd.
K212058	Longeviti ClearFit OTS Cranial Implants	Sep 08, 2021	Substantially Equivalent	Longeviti Neuro Solutions, LLC
K210616	Longeviti PMMA Static Cranial Implant	Mar 31, 2021	Substantially Equivalent	Longeviti Neuro Solutions, LLC
K203349	Longeviti ClearFit Cranial Implant	Dec 16, 2020	Substantially Equivalent	Longeviti Neuro Solutions, LLC
K202901	Longeviti ClearFit Cranial Implant	Oct 30, 2020	Substantially Equivalent	Longeviti Neuro Solutions, LLC
K192702	DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional	Sep 18, 2020	Substantially Equivalent	Synthes (USA) Products, LLC
K193547	CustomizedBone Service	Jan 17, 2020	Substantially Equivalent	Fin-Ceramica Faenza S.P.A.
K191210	Longeviti ClearFit Cranial Implant	Jan 09, 2020	Substantially Equivalent	Longeviti Neuro Solutions, LLC
K180064	OsteoFab Patient Specific Cranial Device	Jul 27, 2018	Substantially Equivalent	Oxford Performance Materials, Inc.
K180513	CustomizedBone Service	May 15, 2018	Substantially Equivalent	Fin-Ceramica Faenza S.P.A.
K170410	Longeviti PMMA Static Cranial Implant	Mar 23, 2018	Substantially Equivalent	Longeviti Neuro Solutions, LLC
K171507	CustomizedBone Service	Sep 01, 2017	Substantially Equivalent	Fin-Ceramica Faenza S.P.A.
K161090	Cranial PSI	Jan 19, 2017	Substantially Equivalent	Ossdsign AB
K160707	CustomizedBone Service	Dec 17, 2016	Substantially Equivalent	Fin-Ceramica Faenza S.P.A.
K151692	BioArchitects Patient Specific Cranial/Craniofacial Plate	Nov 20, 2015	Substantially Equivalent	Bioarchitects USA, LLC
K151382	Patient Contoured Implant-PEEK (PCI-PEEK)	Nov 09, 2015	Substantially Equivalent	KLS Martin L.P.
K130447	SPEEDY FLAP SYSTEM	Dec 22, 2014	Substantially Equivalent	Jeil Medical Corporation
K133082	OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE	May 20, 2014	Substantially Equivalent	Osteosymbionics, LLC
K121818	OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE	Feb 07, 2013	Substantially Equivalent	Oxford Performance Materials
K121755	CUSTOM CRANIOFACIAL IMPLANT (CCI)	Sep 25, 2012	Substantially Equivalent	Kelyniam Global, Inc.
K122353	CRAINFIX 2 TITANIUM CLAMP SYSTEM	Aug 30, 2012	Substantially Equivalent	Aesculap, Inc.
K121102	OSTEOSYMBIONICS PEEK CRANIAL IMPLANT	Aug 08, 2012	Substantially Equivalent	Osteosymbionics, LLC
K110684	MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT	Jun 24, 2011	Substantially Equivalent	Vanduzen Dba Medcad
K103582	KELYNIAM CUSTOM SKULL IMPLANT (CSI)	Apr 14, 2011	Substantially Equivalent	Kelyniam Global, Inc.
K082175	MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION	Aug 13, 2008	Substantially Equivalent	Bioplate, Inc.
K072707	PATIENT CONTOURED MESH-PEEK (PCM-P)	Dec 19, 2007	Substantially Equivalent	KLS-Martin L.P.
K070901	MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM	Jun 15, 2007	Substantially Equivalent	Bioplate, Inc.
K062819	BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY	Dec 04, 2006	Substantially Equivalent	Bioplate, Inc.
K062857	KLS MARTIN QUICK DISC	Nov 22, 2006	Substantially Equivalent	KLS Martin L.P.
K062570	PATIENT CONTOURED MESH (PCM)	Oct 31, 2006	Substantially Equivalent	KLS-Martin L.P.
K052871	STRYKER CUSTOM TI IMPLANT	Dec 16, 2005	Substantially Equivalent	Stryker Leibinger
K053199	SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT	Dec 14, 2005	Substantially Equivalent	Synthes (Usa)
K033868	SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS	Jun 21, 2004	Substantially Equivalent	Synthes (Usa)
K040864	CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM	Jun 17, 2004	Substantially Equivalent	Aesculap
K031034	SPIN DOWN RAPIDFLAP	May 21, 2003	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K022277	OSTEOMED CRANIAL FLAP FIXATION SYSTEM	Apr 01, 2003	Substantially Equivalent	Osteomed Corp.
K030378	STRYKER LEIBINGER CRANIAL FIXATION SYSTEM	Mar 20, 2003	Substantially Equivalent	Stryker Instruments
K020088	MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM	Feb 08, 2002	Substantially Equivalent	Bioplate, Inc.
K013050	THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM	Dec 10, 2001	Substantially Equivalent	Bioplate, Inc.
K013000	MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520	Dec 05, 2001	Substantially Equivalent	Medtronic Neurosurgery
K993990	LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM	Feb 22, 2000	Substantially Equivalent	Stryker Instruments
K992000	SYNTHES CRANIAL FLAP TUBE CLAMP	Jul 20, 1999	Substantially Equivalent	Synthes (Usa)
K991860	SYNTHES CRANIAL FLAP TWIST CLAMP	Jul 20, 1999	Substantially Equivalent	Synthes (Usa)
K991029	RAPIDFLAP CRANIAL CLAMP	Apr 23, 1999	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K971252	SEVRAIN CRANIAL CLAMP	Jul 06, 1998	Substantially Equivalent	Ikonos Corp.
K971408	SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)	May 12, 1998	Substantially Equivalent	Ikonos Corp.
K972332	AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM	Jan 16, 1998	Substantially Equivalent	Aesculap, Inc.