METICULY Patient-specific titanium mesh implant

FDA 510(k) K252958 · Meticuly Co., Ltd.

Substantially Equivalent

510(k) numberK252958

Submission

Device name
METICULY Patient-specific titanium mesh implant
Applicant
Meticuly Co., Ltd.
Bangkok, TH
Received
September 16, 2025
Decision date
January 14, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXN – Plate, Cranioplasty, Preformed, Non-Alterable
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5330
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code GXN

510(k)DeviceApplicantDecision
K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring…GXN · Traditional Longeviti Neuro Solutions06/25/2026SE
K2531163D MAC Titanium Cranial Plate (TCP) SystemGXN · Traditional The Surgeon General, Department of the Army…06/18/2026SE
K252251Easymade-TiGXN · Traditional CG Bio Co., Ltd.04/09/2026SE
K243715Synthes Patient Specific ImplantsGXN · Traditional Synthes GmbH11/12/2025SE
K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…GXN · Traditional KLS-Martin L.P.11/10/2025SE
K240567CustomizedBone ServiceGXN · Special Fin-Ceramica Faenza S.P.A.03/28/2024SE
K231920Longeviti ClearFit OTS Cranial ImplantGXN · Special Longeviti Neuro Solutions, LLC11/09/2023SE
K214109PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)GXN · Traditional Kontour(Xi’An) Medical Technology Co., Ltd.10/28/2022SE
K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantGXN · Traditional Medcad08/26/2022SE
K210099Meticuly Patient-Specific Titanium Mesh ImplantGXN · Traditional Meticuly Co., Ltd.12/21/2021SE

More from Meticuly Co., Ltd.

510(k)DeviceDecision
K253206METICULY Patient-specific CMF solutionJEY · Traditional 07/25/2026SE
K232889METICULY Patient-specific titanium maxillofacial mesh implantJEY · Traditional 04/30/2024SE
K210099Meticuly Patient-Specific Titanium Mesh ImplantGXN · Traditional 12/21/2021SE

Questions and answers

When was METICULY Patient-specific titanium mesh implant cleared by the FDA?

METICULY Patient-specific titanium mesh implant (K252958) received a 510(k) decision of Substantially Equivalent on January 14, 2026, 120 days after the submission was received.

What is the product code of K252958?

The FDA product code is GXN – Plate, Cranioplasty, Preformed, Non-Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5330.