CustomizedBone Service

K171507 · Fin-Ceramica Faenza S.P.A. · GXN · Sep 1, 2017 · Neurology

Device Facts

• Record ID: K171507
• Device Name: CustomizedBone Service
• Applicant: Fin-Ceramica Faenza S.P.A.
• Product Code: GXN · Neurology
• Decision Date: Sep 1, 2017
• 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 above 13 years of age). 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 implants for reconstruction of craniofacial defects. Service utilizes patient imaging data to design and manufacture custom implants tailored to individual anatomy. Implants replace bony voids in frontal bone/brow ridge. Used by surgeons in clinical settings to address defects from trauma, tumor resection, congenital malformations, or previous prosthetic failure. Output is a physical, custom-fit implant intended to restore skeletal structure. Benefits include anatomical fit and structural support for cranial defects.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Patient-specific cranial implant service. Materials and manufacturing specifications not detailed in provided text. Device is a preformed nonalterable cranioplasty plate (21 CFR 882.5330).

Indications for Use

Indicated for adults and pediatric patients >13 years old requiring reconstruction of craniofacial bony voids (frontal bone/brow ridge) due to trauma, vascular pathology, 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 1, 2017

FIN-CERAMICA FAENZA SPA % Mary Beth Henderson, PhD, MBA VP Regulatory Affairs and Quality System, Senior Principal Advisor Regulatory and Clinical Research Institute. Inc. 5353 Wayzata Blvd. Suite 505 Minneapolis, Minnesota 55416

Re: K171507

Trade/Device Name: CustomizedBone Service Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: July 27, 2017 Received: July 28, 2017

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

William J. Heetderks -S 2017.09.01 16:46:37 -04'00'

- 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) K171507

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 above 13 years of age).

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) | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------|
| <table style="border:none;"><tr><td> Reproductive Use (21 CFR 321 Subpart B) </td><td> Over-The-Counter Use (21 CFR 333 Subpart C) </td></tr></table> | Reproductive Use (21 CFR 321 Subpart B) | Over-The-Counter Use (21 CFR 333 Subpart C) |
| Reproductive Use (21 CFR 321 Subpart B) | Over-The-Counter Use (21 CFR 333 Subpart C) | |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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