CustomizedBone Service

K180513 · Fin-Ceramica Faenza S.P.A. · GXN · May 15, 2018 · Neurology

Device Facts

• Record ID: K180513
• Device Name: CustomizedBone Service
• Applicant: Fin-Ceramica Faenza S.P.A.
• Product Code: GXN · Neurology
• Decision Date: May 15, 2018
• Decision: SESE
• Submission Type: Traditional
• 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 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 implants for craniofacial reconstruction. Service utilizes patient imaging data to design and manufacture custom implants to replace bony voids in the frontal bone and brow ridge. Implants are intended for surgical implantation by neurosurgeons or craniofacial surgeons to address defects from trauma, tumor resection, congenital conditions, or previous prosthetic failure. The process involves converting clinical imaging into a physical implant tailored to the patient's anatomy, facilitating structural restoration of the craniofacial skeleton. Benefits include precise anatomical fit and restoration of skeletal integrity.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the device's intended use and technological characteristics.

Technological Characteristics

Patient-specific craniofacial implants designed for reconstruction of the frontal bone and brow ridge. The device is a preformed, nonalterable cranioplasty plate. Technical specifications, materials, and manufacturing standards are not detailed in the provided text.

Indications for Use

Indicated for adult and pediatric patients (≥7 years) requiring reconstruction of craniofacial defects (specifically frontal bone/brow ridge) caused by trauma, vascular pathologies, tumor removal, autologous bone reabsorption, prosthetic 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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May 15, 2018

Fin-Ceramica Faenza S.p.A % Mary Henderson VP Regulatory Affairs and Quality System, Senior Principal Advisor Regulatory and Clinical Research Institute, Inc. 5353 Wayzata Blvd, Suite 505 Minneapolis, Minnesota 55416

Re: K180513

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: February 23, 2018 Received: February 27, 2018

Dear Dr. 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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# Page 2 - Mary Henderson

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Hoffmann -S

Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180513

Device Name CustomizedBone Service

#### Indications for Use (Describe)

CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the 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) |
|--------------------------------------------------------------------------------------------------------------------------|
| <label><input checked="checked" type="checkbox"/> Production Use (21 CFR 201.1 Subject to Labeling Requirements)</label> |
| <label><input type="checkbox"/> Own-Time Copy Use (21 CFR 201.1 Subject to Labeling Requirements)</label> |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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