Who is the manufacturer of Meticuly Patient-Specific Titanium Mesh Implant?

Meticuly Co., Ltd. filed the 510(k) submission for Meticuly Patient-Specific Titanium Mesh Implant (K210099).

What is the FDA product code for Meticuly Patient-Specific Titanium Mesh Implant?

GXN. It is classified under 21 CFR 882.5330 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Meticuly Patient-Specific Titanium Mesh Implant?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Meticuly Patient-Specific Titanium Mesh Implant?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Meticuly Patient-Specific Titanium Mesh Implant

Q: What are the predicate devices for Meticuly Patient-Specific Titanium Mesh Implant?

LaForte Neuro System Bone Plate and Screw (K141452).

K210099 · Meticuly Co., Ltd. · GXN · Dec 21, 2021 · Neurology

Device Facts

Record ID	K210099
Device Name	Meticuly Patient-Specific Titanium Mesh Implant
Applicant	Meticuly Co., Ltd.
Product Code	GXN · Neurology
Decision Date	Dec 21, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5330
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Meticuly patient-specific tianium mesh implant is a device that is designed individually for each patient. This device is intended for use in selective trauma of the craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures.

Device Story

Patient-specific titanium mesh implant; designed individually for each patient using CT scan data. Manufactured via additive manufacturing (Laser Powder Bed Fusion) using Titanium Ti-6Al-4V ELI (Grade 23). Used in cranial/craniofacial surgery to replace bony voids; fixated with commercially available titanium screws (1.4 mm - 1.8 mm). Surgeon approves design prior to fabrication. Device provides structural support for reconstructive procedures; benefits patient by restoring cranial anatomy. Used in clinical settings by surgeons.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via Finite Element Analysis (FEA) for stress/deformation, comparative mechanical compression testing (stiffness/energy absorption), surface roughness testing (ISO 4288/25178), and dimensional fidelity validation against CT source data. Biocompatibility testing performed per ISO 10993 series.

Technological Characteristics

Material: Titanium Ti-6Al-4V ELI (Grade 23) per ASTM F3001-14. Manufacturing: Laser Powder Bed Fusion (additive). Form factor: Patient-specific mesh. Fixation: Titanium screws (1.4-1.8mm). Sterilization: Non-sterile (requires user sterilization).

Indications for Use

Indicated for patients requiring reconstruction of bony voids in the craniofacial skeleton (frontal, temporal, occipital, parietal, sphenoid, supraorbital, vomer) due to selective trauma or surgery.

Regulatory Classification

Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

LaForte Neuro System Bone Plate and Screw (K141452)

Reference Devices

BioArchitects Patient Specific Cranial/Craniofacial Plate (K151692)

Related Devices

K252958 — METICULY Patient-specific titanium mesh implant · Meticuly Co., Ltd. · Jan 14, 2026
K173039 — TruMatch CMF Titanium 3D Printed Implant · Materialise NV · Jul 10, 2018
K232889 — METICULY Patient-specific titanium maxillofacial mesh implant · Meticuly Co., Ltd. · Apr 30, 2024
K232350 — Stryker Facial iD System · Stryker Craniomaxillofacial · Jan 13, 2024
K151692 — BioArchitects Patient Specific Cranial/Craniofacial Plate · Bioarchitects USA, LLC · Nov 20, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 21, 2021 Meticuly Co., Ltd. Peeranoot Lohwongwatana Managing Director 32/77, Soi Samakkee 58/20, Samakkee rd., Tasai Muang Nonthaburi, Nonthaburi 11000, Thailand Re: K210099 Trade/Device Name: Meticuly Patient-Specific Titanium Mesh Implant Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: November 17, 2021 Received: November 22, 2021 Dear Peeranoot Lohwongwatana: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210099 Device Name Meticuly Patient-specific Titanium Mesh Implant Indications for Use (Describe) Meticuly patient-specific tianium mesh implant is a device that is designed individually for each patient. This device is intended for use in selective trauma of the craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures. Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary K210099 The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary of the K210099 Meticuly Patient-Specific Titanium Mesh Implant: # 1. Submitter Information | Company/Applicant: | Mrs. Peeranoot Lohwongwatana | |------------------------|---------------------------------------------| | | Managing Director | | | Meticuly Co., Ltd. | | | 924 B bldg., Rm. B116-118, B210-212 | | | Soi Chula 7, Wang Mai, Pathum Wan | | | Bangkok, Thailand 10330 | | | Telephone: +6688-834-7777 | | | Email: peeranoot@meticuly.com | | Contact: | Paweena U-Thainual, PhD | | | MDR Solutions Co., Ltd. | | | 1435, Kanjanapisek Rd., Bang Khae Nuea | | | Bang Khae, Bangkok 10160 Thailand | | | Telephone: +662-804-2101 | | | Email: paweena@mdrsolutions.co.th | | Date Summary Prepared: | December 13, 2021 | | 2. Device Name | | | Trade Name: | Meticuly Patient-Specific Titanium Mesh | | Common Name: | Implant Preformed Nonalterable Cranioplasty | | Classification Name: | Plate Neurology | | Review Panel: | Neurology (NE) | | Regulation: | 882.5330 | | Class: | Class II | | Product Code: | GXN | # 3. Predicate Device Meticuly Patient-specific Titanium Mesh Implant is substantially equivalent to the following legally marketed predicate device: {4}------------------------------------------------ | Applicant | Device Name | 510(k) Number | |-----------------------------|-------------------------------------------|---------------| | Jeil Medical Corporation | LaForte Neuro System Bone Plate and Screw | K141452 | #### Table 1.1 Primary Predicate device Table 1.2 Reference device* | Applicant | Device Name | 510(k) Number | |-------------------------|--------------------------------------------------------------|---------------| | BioArchitects USA, LLC. | BioArchitects Patient Specific Cranial/Craniofacial Plate | K151692 | *This device is referred to support the use of a similar material and manufacturing for the subject device #### 4. Description Meticuly's Patient-specific Titanium Mesh Implant is a device designed individually to replace each patient's bony voids in the cranial and/or craniofacial skeleton comprises of frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer. This patient-specific device is intended to be used with titanium screws. The subject device has been validated and tested with titanium screws with the diameter of 1.4 mm - 1.8 mm (K141452 : Jeil Medical's LeForte Neuro system screws). The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The surgeon approves the design of the mesh implant prior to fabrication of the implant device. #### 5. Indications for Use Meticuly Patient-specific Titanium Mesh Implant is a device that is designed individually for each patient. This device is intended for use in selective trauma of the cranial and craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures. #### 6. Comparison of Technological Characteristics with the Predicate Device The subject device is substantially equivalent to the following legally marketed predicate devices. Meticuly Patient-specific Titanium Mesh Implant and the predicate devices have the similar characteristics, for example, indication for use, intended use, sterilization method, manufacturing method, device design, and device performance. The differences of these characteristics have been addressed with the provided performance test data in this submission and do not raised different questions of safety and effectiveness. | Table 2: Technical Characteristics in Comparison to the Predicate and Reference Devices | | | | |-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Device comparison | Subject Device: Meticuly Patient-specific Titanium Mesh Implant | Predicate Device: LeForte Neuro System Bone Plate and Screw | Reference Device: BioArchitects Patient Specific Cranial/Craniofacial Plate | | 510(K) number | K210099 | K141452 | K151692 | | Product Code(s) | GXN | GWO, GXR, HBW | GXN | {5}------------------------------------------------ | 510(k) Summary | |----------------| | | | Table 2: Technical Characteristics in Comparison to the Predicate and Reference Devices | | | | |-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device comparison | Subject Device: Meticuly Patient-specific Titanium Mesh Implant | Predicate Device: LeForte Neuro System Bone Plate and Screw | Reference Device: BioArchitects Patient Specific Cranial/Craniofacial Plate | | Classification | Class II | Class II | Class II | | Indications for Use | Meticuly Patient-specific Titanium Mesh Implant is a device that is designed individually for each patient. This device is intended for use in selective trauma of the cranial and craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures. | This device is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures. | The BioArchitects Patient Specific Cranial/Craniofacial Plate implant device is intended to replace bony voids in the cranial and/or craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, sphenoid bone, ethmoid process, vomer). It is a patient specific device. | | Material(s) | Titanium Ti-6Al-4V ELI (Grade23) | Commercially pure Titanium | Titanium alloy (Ti-6Al-4V ELI) | | Technical Specifications | Custom-made to each patient using CT data | Custom sized to each patient | Custom-made to each patient using CT or MRI data | | Manufacturing Method | 3D printed using laser powder bed fusion additive manufacturing | Machined and surface treated by anodization | 3D printed using electron beam melting additive manufacturing | | Fixation Method | Commercially available titanium screws systems | Own plate and screw system | Commercially available titanium screws systems | | Sterilization | Non-sterile | Non-sterile | Non-sterile | # 7. Performance Tests Materials and manufacturing method quality of Meticuly Patient-specific Titanium Mesh Implant were assessed through physical properties and mechanical properties. The device testing was designed to validate the manufacturing process and to ensure that the subject device complicable voluntary consensus standards for biocompatibility, packaging, transportation, and sterilization and validation testing confirms that the product specifications have been met, demonstrating that the device will perform as intended. There were no unexpected results which indicate the suitable material used and manufacturing process compared to the standards for medical devices. {6}------------------------------------------------ | Table 3: Testing and compliance standards summary table | | |---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Test | Standard (FDA recognition number) | | Materials and manufacturing method | ASTM F3001-14 (8-439) Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion | | Biological evaluation and Biocompatibility | ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials ISO 10993-1 Fourth edition 2009-10-15 (2-220) Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)] ISO 10993-3 Third edition 2014-10-1 (2-228) Biological evaluation of medical devices - Part 3:Tests for genotoxicity carcinogenicity and reproductive toxicity ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood ISO 10993-5 Third edition 2009-06-01 (2-245) Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity ISO 10993-6 Third edition 2016-12-01 (20247) Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation ISO 10993-10 Third Edition 2010-08-01 (2-174) Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization ISO 10993-11 Third edition 2017-09 (2-255) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | | Table 3: Testing and compliance standards summary table | | | Test | Standard (FDA recognition number) | | Sterilization process control and validation | ANSI AAMI ST72:2011/(R)2016 (14-360) Bacterial endotoxins - Test methods routine monitoring and alternatives to batch testing | | | USP 42-NF37:2019 <85> Bacterial Endotoxins Test (14-533) | | | USP 42-NF37:2019 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests (14-534) | | | ISO 17665-1 First edition 2006-08-15 (14-333) Sterilization of health care products - Moist heat - Part1: Requirements for the development validation and routine control of a sterilization process for medical devices | | | ISO 11737-1 Third edition 2018-01 (14-514) Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product | | | ISO 11737-2 Third edition 2019-12 (14-540) Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition validation and maintenance of a sterilization process | | Packaging and transportation control and validation | ASTM F88/F88M-15 (14-482) Standard Test Method for Seal Strength of Flexible Barrier Materials | | | ASTM D7386-16 (5-113) Standard Practice for Performance Testing of Packages for Single Delivery Systems | {7}------------------------------------------------ #### 8. Pre-clinical performance test The Meticuly Patient-specific Titanium Mesh Implant was mechanically tested for tensile and elastic strength, with test results similar to those of predicates. The performance of the subject device was assessed through three comparative tests. According to the Meticuly Patient-specific Titanium Mesh Implant is considered substantially equivalent to the predicate device. {8}------------------------------------------------ | Table 4: Performance testing summary table | | | |----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Test | Test method summary | Results | | Comparative device modeling with Finite Element Analysis (FEA) | Computational simulation was performed with a compression load in the normal direction on the center of the mesh implant. The load was applied on the surface of the implant. This static loading represents a simulation of a relaxed person resting on a pillow. | The FEA consideration is based on maximum equivalent stress, safety factor and maximum deformation. The result of the comparative test shows that the subject device is substantially equivalent to the predicate device. | | Comparative mechanical testing with modified compression test | - The subject device and the predicate device were designed or shaped into a similar design. Both subject device and predicate device were fixated onto the plastic anatomic model that represented the skull with screws. - Compression test was performed under the displacement control to maximum displacement in the normal direction on the center of the mesh implant. | The mechanical consideration is based on the stiffness and energy absorption. The result of the comparative test shows that the subject device is substantially equivalent to the predicate device. | | Comparative roughness testing via non-contact method | The surface roughness evaluation was performed following the ISO 4288 and ISO 25178. | The result of the comparative test shows that the subject device is substantially equivalent to the predicate device. | | Device fidelity and validation of device dimensional fit | Confirm the design qualification and fidelity of the device with the quality instruments. | The results show the fidelity of the device and the traceability between the CT scan data and the final product. | #### 9. Conclusion Based upon testing and comparison to the predicate device, the Meticuly Patient-specific Titanium Mesh Implant has the same intended use and similar technological characteristics. The device performs as intended and does not raise new questions of safety or effectiveness; Thus, the subject device is concluded to be substantially equivalent to the legally commercialized predicate devices for the purposes of this 510(k) submission.