CustomizedBone Service

K193547 · Fin-Ceramica Faenza S.P.A. · GXN · Jan 17, 2020 · Neurology

Device Facts

• Record ID: K193547
• Device Name: CustomizedBone Service
• Applicant: Fin-Ceramica Faenza S.P.A.
• Product Code: GXN · Neurology
• Decision Date: Jan 17, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and /or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above). CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from: - trauma and vascular pathologies, either associated or non-associated to cranial decompression: - removal of tumours: - reabsorption of autologous bone: - rejection of other prosthetic materials: - congenital malformations.

Device Story

CustomizedBone Service provides patient-specific cranial and craniofacial implants. The service utilizes patient imaging data to design and manufacture custom implants for replacing bony voids. Used in clinical settings by neurosurgeons or craniofacial surgeons to reconstruct defects caused by trauma, tumor resection, or congenital conditions. The output is a physical, custom-fit implant that restores skeletal anatomy, potentially improving patient aesthetic and functional outcomes. The process involves translating patient-specific anatomical data into a manufactured implant.

Indications for Use

Indicated for adult and pediatric patients (≥7 years) requiring reconstruction of cranial or craniofacial (frontal bone/brow ridge) bony voids due to trauma, vascular pathologies, tumor removal, autologous bone reabsorption, prosthetic material rejection, or congenital malformations.

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.

Submission Summary (Full Text)

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January 17, 2020

Fin-Ceramica Faenza Spa % Mary Beth Henderson, Ph.D., M.B.A. VP Regulatory Affairs and Quality System, System, Senior Principal Advisor Regulatory and Clinical Research Institute, Inc. 5353 Wayzata Blvd, Suite 505 Minneapolis, Minnesota 55416

Re: K193547

Trade/Device Name: CustomizedBone Service Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN, PJN Dated: December 19, 2019 Received: December 20, 2019

Dear Mary Beth Henderson:

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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Matthew Krueger, M.S.E. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K193547

Device Name CustomizedBone Service

## Indications for Use (Describe)

CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and /or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above).

CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:

- · trauma and vascular pathologies, either associated or non-associated to cranial decompression:
- · removal of tumours:
- · reabsorption of autologous bone:
- rejection of other prosthetic materials:
- · congenital malformations.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="true" type="checkbox"/> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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