TruMatch CMF Titanium 3D Printed Implant

K173039 · Materialise NV · JEY · Jul 10, 2018 · Dental

Device Facts

• Record ID: K173039
• Device Name: TruMatch CMF Titanium 3D Printed Implant
• Applicant: Materialise NV
• Product Code: JEY · Dental
• Decision Date: Jul 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TruMatch CMF Titanium 3D Printed Implant is a patient specific implant and is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface and chin.

Device Story

Patient-specific implant; manufactured via additive manufacturing using commercially pure titanium; features mesh-like structure for osseointegration. Input: patient CT imaging data. Output: custom-fit titanium implant. Used in plastic and reconstructive surgery; operated by surgeons. Integrated screw holes allow fixation using compatible Synthes screw systems. Guides aid in positioning. Device provides structural continuity or augmentation in maxillofacial regions. Benefits: patient-specific anatomical fit; eliminates manual contouring by surgeon.

Clinical Evidence

Bench testing only. Mechanical performance tested per ASTM F382; results showed equivalent static bending and non-inferior fatigue properties. Sterilization validated per ISO 17665-1, ISO 14161, and ISO 11737-2 to SAL 10^-6. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, chemical characterization, and leachable substances assessment) with all tests passing. Packaging validated per ISTA 2A.

Technological Characteristics

Material: Commercially pure titanium. Manufacturing: Additive manufacturing. Form factor: Patient-specific mesh-like structure. Dimensions: Thickness 0.4-10mm, length 10-294mm. Fixation: Integrated screw holes for compatible Synthes screw systems. Sterilization: Moist heat (not provided sterile).

Indications for Use

Indicated for bone fixation, reconstruction, restoration of bone defects, and bone augmentation in the maxillofacial skeleton, midface, and chin.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• TruMatch CMF Titanium 3D Printed Implant System (K170272)

Reference Devices

• OsteoFab Patient Specific Facial Device (K133809)
• Synthes MatrixMANDIBLE Plate and Screw System (K063790)
• Synthes Craniofacial Plate and Screw System (K080331)
• Synthes Matrixorthognathis Fixation System (K083388)
• The Synthes (USA) Neuro Plate and Screw System (K042365)
• Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199)
• SurgiCase guides (K103136)
• MatrixMIDFACE (K050608)
• MatrixMANDIBLE (K121574)
• MatrixNEURO screws (K123723)

Submission Summary (Full Text)

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July 10, 2018

Materialise NV Lina Ramirez Regulatory Officer Technologielaan 15 Leuven, 3001 BELGIUM

Re: K173039

Trade/Device Name: TruMatch CMF Titanium 3D Printed Implant Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: June 8, 2018 Received: June 11, 2018

Dear Lina Ramirez:

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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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 comprehensive regulatory information about medical devices and radiation-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.

# Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K173039

Device Name TruMatch CMF Titanium 3D Printed Implant

#### Indications for Use (Describe)

The TruMatch CMF Titanium 3D Printed Implant is a patient specific implant and is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface and chin.

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

| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|------------------------------------------------------------|
| <span></span> | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### K173039- 510(k) SUMMARY

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92

## Submitter information

| Company name | Materialise N.V. |
|-----------------------------------|-----------------------------------|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Zip code | 3001 |
| Country | Belgium |
| Phone number | [phone] |
| Fax number | [phone] |
| Principal contact person | Lina Ramirez |
| Contact title | Regulatory Officer |
| Contact e-mail address | [e-mail] |
| Additional contact person | Mieke Janssen |
| Contact title | Senior Regulatory Officer |
| Contact e-mail address | [e-mail] |

## Date of preparation

This summary was last updated on July 9, 2018.

## Submission information

| | TruMatch CMF Titanium 3D Printed Implant |
|------------------------------------------|--------------------------------------------------------------------------------------|
| Trade name(s) | TruMatch CMF Ti 3D-Printed Plates and TruMatch CMF Ti 3D-<br>Printed Surgical Guides |
| | TruMatch CMF Ti 3D-Printed Implants. |
| Common or Usual name | Bone plate |
| Classification name | Bone plate |
| Product code (classification regulation) | JEY |
| Classification Panel | Dental |
| Device class | Class II (21 CFR 872.4760) |

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# Predicate device

The predicate device to which substantial equivalence is claimed to:

| TruMatch CMF Titanium 3D Printed Implant System | |
|-------------------------------------------------|-------------------------------------------------|
| Bone plate and screw | |
| Trade or proprietary or model name | TruMatch CMF Titanium 3D Printed Implant System |
| 510(k) number | K170272 |
| Decision date | 08/08/2017 |
| Product code | JEY (21 CFR 872.4760) |
| Manufacturer | Materialise N.V. |

# Reference devices:

| OsteoFab Patient Specific Facial Device - OPSFD | |
|-------------------------------------------------|-----------------------------------------|
| Bone plate and screw | |
| Trade or proprietary or model name | OsteoFab patient Specific facial Device |
| 510(k) number | K133809 |
| Decision date | 07/28/2014 |
| Product code | KKY (21 CFR 878.3500) |
| Manufacturer | Oxford Performance Materials, Inc. |

| Synthes MatrixMANDIBLE Plate and Screw System | |
|-----------------------------------------------|-----------------------------------------------|
| Bone plate and screw | |
| Trade or proprietary or model name | Synthes MatrixMANDIBLE Plate and Screw System |
| 510(k) number | K063790 |
| Decision date | 04/16/2007 |
| Product code | JEY (21 CFR 872.4760) |
| Manufacturer | Synthes (USA) |

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| Synthes Craniofacial Plate and Screw System | | | | |
|---------------------------------------------|---------------------------------------------|--|--|--|
| Bone plate and screw | | | | |
| Trade or proprietary or model name | Synthes Craniofacial Plate and Screw System | | | |
| 510(k) number | K080331 | | | |
| Decision date | 04/30/2008 | | | |
| Product code | JEY (21 CFR 872.4760) | | | |
| Manufacturer | Synthes (USA) | | | |

| Synthes Matrixorthognathis Fixation System | |
|--------------------------------------------|--------------------------------------------|
| Bone plate and screw | |
| Trade or proprietary or model name | Synthes Matrixorthognathis Fixation System |
| 510(k) number | K083388 |
| Decision date | 03/12/2009 |
| Product code | JEY (21 CFR 872.4760) |
| Manufacturer | Synthes (USA) |

| The Synthes (USA) Neuro Plate and Screw System | |
|------------------------------------------------|------------------------------------------------|
| Bone plate and screw | |
| Trade or proprietary or model name | The Synthes (USA) Neuro Plate and Screw System |
| 510(k) number | K042365 |
| Decision date | 11/18/2004 |
| Product code | JEY |
| Manufacturer | Synthes (USA) |
| | |

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| Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) | |
|--------------------------------------------------------------|--------------------------------------------------------------|
| Plate, Cranioplasty, preformed, non-alterable | |
| Trade or proprietary or model name | Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) |
| 510(k) number | K053199 |
| Decision date | 12/14/2005 |
| Product code | GXN (21 CRF) 882.5330 |
| Manufacturer | Synthes (USA) |

### Device Information

### Indications for use

The TruMatch CMF Titanium 3D Printed Implant is a patient specific implant and is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface and chin.

### Device Description

The TruMatch CMF Titanium 3D Printed Implant is a patient specific implant and is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface and chin.

The implants feature a mesh-like structure. The mesh-like structures are designed with the same elementary pattern. This pattern was designed to obtain implants with mechanical properties close to those of bone and to allow for osseointegration.

The TruMatch CMF Titanium 3D Printed Implant can be used in combination with TruMatch CMF Titanium 3D Printed Accessories (patient-specific guides), cleared as SurgiCase guides (K103136) and TruMatch CMF Titanium 3D Printed Implant System (K170272). The guides are intended to aid with implant positioning.

The TruMatch CMF Titanium 3D Printed Implant provides surgeons with a patient-specific implant solution for plastic and reconstructive surgery. The device is constructed based on the patient's CT imaging data.

The TruMatch CMF Titanium 3D Printed Implant is designed to fit the patient's anatomy and is not contoured manually by the surgeon. The TruMatch CMF Titanium 3D Printed Implant is designed and manufactured with integrated screw holes to fixate the bone using: MatrixMIDFACE (K050608), MatrixMANDIBLE (K063790, K121574), MatrixORTHOGNATHIC (K083388), MatrixNEURO screws (K123723, K042365), and Synthes Craniofacial Screw System (K050608).

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The TruMatch CMF Titanium 3D Printed Implant contains the following applications:

| Reconstruction applications: Orbital | | |
|--------------------------------------|-------------------------------------|----------------------------------------|
| Brand name | TruMatch CMF Ti 3D-Printed Implants | |
| Material | Commercially pure titanium | |
| Type of design | Patient Specific | |
| Type of application | Implant thickness | Patient specific associated instrument |
| Orbital implants | 0.4-1.5mm | Orbital guide |

| Reconstruction applications: Mandible, midface | | | |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------------------------|
| Brand name | TruMatch CMF Ti 3D-Printed Implant | | |
| Material | Commercially pure titanium | | |
| Type of design | Patient Specific | | |
| Range of length | 10-294mm | | |
| Curvature | 0°-12°/mm length | | |
| Type of application | Range of shapes | Implant thickness | Patient specific associated instrument |
| Midface reconstruction | Mesh-shaped, contoured to the patient's anatomy One/multi piece One/multi layered | 0.8-10mm | Midface guide |
| Mandibular reconstruction | Mesh-shaped, contoured to patient's anatomy Single/double strut Straight Curved/crescent Subcondylar Plated extensions One/multi layered Combinations of the above | 1.2-10mm | Mandibular guide |

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# Comparison to the Predicate Device

Intended use:

| | Subject device:<br>TruMatch CMF 3D Printed Implants<br>(K173039) | Predicate device:<br>TruMatch CMF 3D Printed Implant System<br>(K170272) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | JEY | JEY |
| Classification | Class II | Class II |
| Intended Use | The TruMatch CMF Titanium 3D Printed<br>Implant is a patient specific Implant and<br>is intended for bone fixation and<br>reconstruction, restoration of bone<br>defects and intended to provide<br>continuity in regions where the bone is<br>missing and/or to augment the bone by<br>means of an onlay device in the<br>maxillofacial skeleton, midface and chin. | The TruMatch CMF 3D Printed Implant<br>System is intended for bone repositioning,<br>fixation and reconstruction of the<br>maxillofacial skeleton, midface, mandible<br>and chin in adolescents (greater than 12 to<br>21 years of age) and adults.<br><br>Specific indications for use:<br>● Orthognathic surgery.<br>● Reconstructive mandible and<br>maxillofacial surgery.<br>● Mandible and maxillofacial trauma<br>surgery. |

Both the subject device and the predicate device have the same indications for use: bone fixation and reconstruction in the maxillofacial skeleton, midface and chin. Both devices are used in the same anatomical regions. The subject device and the reference device (OsteoFab Patient Specific Facial Device – OPSFD), are both intended for bone augmentation/enhancement.

| | Subject device: | Predicate device: |
|----------------------------|----------------------------------------|----------------------------------------------|
| | TruMatch CMF Titanium 3D Printed | 3D<br>TruMatch CMF<br>Titanium<br>Printed |
| | Implants | Implant System |
| | | |
| | (K173039) | (K170272) |
| Product code | JEY | JEY |
| Classification | Class II | Class II |
| Technical<br>specification | Bone plate | Bone plate |
| Fixation method | Synthes screw system | Synthes screw system |
| Material(s) | Commercially pure titanium | Commercially pure titanium |
| Manufacturing<br>method | Additive manufacturing | Additive manufacturing |
| Provided<br>sterile? | No | No |
| Sterilization<br>method | Moist heat | Moist heat |
| Device<br>thickness | 0.4 mm – 10 mm | 0.8 mm - 3.0 mm |
| Patient-specific | Yes. Devices are manufactured patient- | Yes. Devices are manufactured patient- |
| configuration? | specific, based on a CT scan of the | specific, based on a CT scan of the patient. |
| | patient. | |

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Both the subject and the predicate device are manufactured in commercially pure titanium. The subject device and the predicate device are fixed with screws.

Both the subject device and the predicate device are not provided sterile and have the same sterilization method, moist heat.

The subject device and the predicate device use an additive manufacturing technique to manufacture the implants. The subject device and the predicate are manufactured from commercially pure titanium in a mesh-like structure, and can be used with accessories (patientspecific guides).

The subject device and predicate device are made patient specific, manufactured from patient CT scan data.

The thickness range of the subject device falls into the thickness range of the predicate and the reference devices.

### Performance data

The following non-clinical testing was conducted as a basis for the determination of substantial equivalence:

| Test | Test method summary | Results |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanical testing | ASTM F382: Standard<br>Specification and Test Method<br>for Metallic Bone Plates | The results of this test indicate<br>that the subject device has<br>equivalent static bending<br>properties and has non-inferior<br>fatigue bending properties<br>compared to the reference<br>devices. |
| Sterilization testing | Steam sterilization validation<br>according to ISO 17665-1 and<br>ISO 14161, ISO11737-2:2009 | The provided sterilization<br>instructions effectively steam<br>sterilize the subject device to a<br>SAL of 10-6. |
| Environmental conditioning<br>and simulated shipping<br>testing | According to ISTA 2A | The packaging specifications are<br>found to be adequate to protect<br>the device from damage during<br>shipment. |
| Compatibility testing | Combination of user need<br>validation lab and engineering<br>rationale | The subject device is compatible<br>with the Synthes fixation<br>systems. |

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| Biocompatibility test overview | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Test/assessment description | Test report conclusion |
| • Cytotoxicity:<br>ISO 10993-5: Tests for in-vitro cytotoxicity -<br>L929 Neutral red uptake Cytotoxicity | - no cytotoxic effect |
| • Sensitization:<br>ISO 10993-10: Tests for irritation and<br>delayed-type hypersensitivity - Kligman<br>Maximization test | - in compliance with requirements of the ISO<br>10993-10 guidelines |
| • Intra-cutaneous reactivity:<br>ISO 10993-10: Tests for irritation and<br>delayed-type hypersensitivity - Intra-<br>cutaneous Injection Test | - in compliance with requirements of the ISO<br>10993-10 guidelines |
| • Systemic toxicity:<br>ISO 10993-11: Tests for systemic toxicity -<br>Systemic injection test | - test passed and is considered negative based<br>on standards set by ISO 10993-11 |
| • Chemical characterization:<br>ISO10993-18: Biological Evaluation of<br>Medical Devices - Part 18: Chemical<br>Characterization of Materials (2005) | - chemical characterization as per report |
| • Assessment of allowable limits for leachable<br>substances:<br>ISO 10993-17 (2009) "Biological evaluation<br>of medical devices — Part 17: Establishment<br>of allowable limits for leachable substances" | - no toxicological concern remains<br>- further biological testing are considered not<br>justified |

The following nonclinical tests were conducted on the TruMatch CMF Titanium 3D Printed Implant as a basis for the determination of substantial equivalence: Performance testing of the TruMatch CMF Titanium 3D Printed implants and accessories, including

- Mechanical performance of the subject device compared to the predicate and reference devices
- Compatibility testing
- . Biocompatibility testing
- Sterilization testing
- . Environmental conditioning and simulated shipping testing

### Conclusion

Non-clinical tests demonstrate that the TruMatch CMF Titanium 3D Printed Implant is substantially equivalent to the predicate device.