Meticuly Patient-Specific Titanium Mesh Implant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252958 FDA 510(k)
- FDA Product Code
- GXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5330 FDA 510(k)
- Regulation Number
- 882.5330 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Meticuly Patient-Specific Titanium Mesh Implant is a preformed, non-alterable cranioplasty plate designed for cranial reconstruction. This device is constructed from titanium and is customised to match individual patient anatomy, providing a tailored solution for cranial defect repair.
Intended for single-use in neurosurgical settings, the implant is supplied sterile and requires no alteration post-manufacture. It is classified as a Class II device under FDA regulation (product code GXN) and has received FDA 510(k) clearance via the Traditional pathway. Storage and handling must adhere to sterile medical device protocols.
Frequently asked questions
What is the Meticuly Patient-Specific Titanium Mesh Implant used for in clinical practice?
The Meticuly Patient-Specific Titanium Mesh Implant is designed specifically for cranial reconstruction in neurosurgical settings. It is a preformed, custom-made titanium mesh tailored to match an individual patient’s anatomy, providing a precise solution for repairing cranial defects.
Is the implant reusable or intended for single-use, and why?
The implant is intended for single-use only in neurosurgical procedures. This is explicitly stated in the device description, as it is supplied sterile and requires no post-manufacture alterations, which would compromise sterility if reused.
How is the implant supplied, and what storage precautions should be taken?
The implant is supplied sterile and preformed, meaning it arrives ready for immediate use without additional preparation. Since it is a sterile medical device, storage and handling must strictly follow sterile medical device protocols to maintain integrity until use.
What regulatory pathway was used for FDA clearance, and what does that mean for buyers?
The Meticuly Patient-Specific Titanium Mesh Implant received FDA 510(k) clearance through the Traditional pathway, meaning its safety and effectiveness were compared to a legally marketed predicate device. This clearance confirms it meets FDA standards for Class II devices (product code GXN) and is suitable for cranial reconstruction as described.
Are there different sizes or models available, and how are they customized?
The implant is patient-specific, meaning each device is custom-designed to match an individual patient’s cranial anatomy. While no generic sizes are listed, the customization process ensures a precise fit for the intended surgical application, eliminating the need for on-site modifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Meticuly | 3D printed Patient-Specific Implants, Products - Meticuly, K252958 - METICULY Patient-specific titanium mesh implant
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252958 | Class II | Active |
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Manufacturer
- Manufacturer
- Meticuly Co., Ltd.
Sources (1)
- FDA 510(k) K252958 24 fields · synced Sep 19, 2026