GXN · Class II · 21 CFR 882.5330

FDA Product Code GXN: Plate, Cranioplasty, Preformed, Non-alterable

Leading manufacturers include Longeviti Neuro Solutions, LLC, KLS-Martin L.P. and Synthes (Usa).

57
Total
57
Cleared
155d
Avg days
1998
Since
Growing category - 6 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 200d recently vs 149d historically

FDA 510(k) Cleared Plate, Cranioplasty, Preformed, Non-alterable Devices (Product Code GXN)

57 devices
1–24 of 57
Cleared Apr 09, 2026
EASYMADE-TI
K252251
CG Bio Co., Ltd.
Neurology · 265d
Cleared Jan 14, 2026
METICULY Patient-specific titanium mesh implant
K252958
Meticuly Co., Ltd.
Neurology · 120d
Cleared Nov 12, 2025
Synthes Patient Specific Implants
K243715
Synthes GmbH
Neurology · 345d
Cleared Nov 10, 2025
KLS Martin Cranial Implants - MR Conditional
K252573
KLS-Martin L.P.
Neurology · 88d
Cleared Mar 28, 2024
CustomizedBone Service
K240567
Fin-Ceramica Faenza S.P.A.
Neurology · 28d
Cleared Nov 09, 2023
Longeviti ClearFit OTS Cranial Implant
K231920
Longeviti Neuro Solutions, LLC
Neurology · 133d
Cleared Oct 28, 2022
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
K214109
Kontour(Xi?An) Medical Technology Co., Ltd.
Neurology · 303d
Cleared Aug 26, 2022
MedCAD AccuShape Titanium Patient-Specific Cranial Implant
K220357
Medcad
Neurology · 199d
Cleared Dec 21, 2021
Meticuly Patient-Specific Titanium Mesh Implant
K210099
Meticuly Co., Ltd.
Neurology · 341d
Cleared Sep 08, 2021
Longeviti ClearFit™ OTS Cranial Implants
K212058
Longeviti Neuro Solutions, LLC
Neurology · 69d
Cleared Mar 31, 2021
Longeviti PMMA Static Cranial Implant
K210616
Longeviti Neuro Solutions, LLC
Neurology · 30d
Cleared Dec 16, 2020
Longeviti ClearFit Cranial Implant
K203349
Longeviti Neuro Solutions, LLC
Neurology · 33d
Cleared Oct 30, 2020
Longeviti ClearFit Cranial Implant
K202901
Longeviti Neuro Solutions, LLC
Neurology · 31d
Cleared Sep 18, 2020
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
K192702
Synthes USA Products, LLC
Neurology · 357d
Cleared Jan 17, 2020
CustomizedBone Service
K193547
Fin-Ceramica Faenza S.P.A.
Neurology · 28d
Cleared Jan 09, 2020
Longeviti ClearFit Cranial Implant
K191210
Longeviti Neuro Solutions, LLC
Neurology · 248d
Cleared Jul 27, 2018
OsteoFab Patient Specific Cranial Device
K180064
Oxford Performance Materials, Inc.
Neurology · 199d
Cleared May 15, 2018
CustomizedBone Service
K180513
Fin-Ceramica Faenza S.P.A.
Neurology · 77d
Cleared Mar 23, 2018
Longeviti PMMA Static Cranial Implant
K170410
Longeviti Neuro Solutions, LLC
Neurology · 406d
Cleared Nov 09, 2015
Patient Contoured Implant-PEEK (PCI-PEEK)
K151382
KLS-Martin L.P.
Neurology · 171d
Cleared Dec 22, 2014
SPEEDY FLAP SYSTEM
K130447
Jeil Medical Corporation
Neurology · 669d
Cleared Aug 30, 2012
CRAINFIX 2 TITANIUM CLAMP SYSTEM
K122353
Aesculap, Inc.
Neurology · 27d
Cleared Dec 19, 2007
PATIENT CONTOURED MESH-PEEK (PCM-P)
K072707
KLS-Martin L.P.
Neurology · 85d
Cleared Nov 22, 2006
KLS MARTIN QUICK DISC
K062857
KLS-Martin L.P.
Neurology · 58d

About Product Code GXN - Regulatory Context

510(k) Submission Activity

57 total 510(k) submissions under product code GXN since 1998, with 57 receiving FDA clearance (average review time: 155 days).

Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GXN Product Code

Recent submissions under GXN have taken an average of 200 days to reach a decision - up from 149 days historically. Manufacturers should account for longer review timelines in current project planning.

GXN devices are reviewed by the Neurology panel. Browse all Neurology devices →