Stryker Facial iD Plating System

K182305 · Stryker · JEY · Jan 7, 2019 · Dental

Device Facts

• Record ID: K182305
• Device Name: Stryker Facial iD Plating System
• Applicant: Stryker
• Product Code: JEY · Dental
• Decision Date: Jan 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Facial iD Plating System is intented for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher). Specific Indications for Use: -Orthognathic surgery -Reconstructive maxillofacial surgery -Mandible and maxillofacial trauma surgery.

Device Story

Stryker Facial iD Plating System provides patient-specific, additively manufactured titanium plates for maxillofacial reconstruction, stabilization, and fracture fixation. System utilizes patient CT/CBCT imaging to generate anatomical models and custom plate designs tailored to individual patient needs. Surgeon reviews and approves design proposal; system provides printed design, electronic IFU, and optional anatomical model. Compatible with separately provided marking/cutting/drill guides. Used in clinical settings by surgeons for orthognathic, reconstructive, and trauma procedures. Plates are non-sterile, requiring moist heat sterilization before use. Device facilitates precise anatomical fit, potentially improving surgical outcomes and reducing operative time compared to manual bending of standard plates.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including mechanical static/fatigue bending strength (ASTM F382), biocompatibility (ISO 10993 series), sterilization validation (ISO 17665-1), cleaning validation (ANSI/AAMI TRI 30), and software workflow output validation.

Technological Characteristics

Patient-specific plates made of commercially pure titanium. Additive manufacturing. Plate profiles 0.8–1.7 mm; bar widths 2.5–7.25 mm. Compatible with 1.7 mm and 2.0 mm screw systems. Non-sterile; moist heat sterilization. Software-driven design process using CT/CBCT data. Complies with ASTM F382 (metallic bone plates) and ISO 10993 (biocompatibility).

Indications for Use

Indicated for osteotomy, stabilization of maxillofacial fractures, and reconstruction in adults and adolescents (age 12+). Specific applications include orthognathic surgery, reconstructive maxillofacial surgery, and mandible/maxillofacial trauma surgery.

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

• Stryker Universal CMF System (K022185)
• Stryker Customized Mandible Recon Plate Kit (K132519)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 7, 2018

Stryker Zainab Amini Regulatory Affairs Specialist 750 Trade Centre Way - Suite 200 Portage, Michigan 49002

Re: K182305

Trade/Device Name: Stryker Facial iD Plating System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: December 6, 2018 Received: December 10, 2018

Dear Zainab Amini:

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Mary S. Mary S. Runner -S Runner -S3 Date: 2019.01.07

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

#### 510(k) Number (if known) K182305

#### Device Name Stryker Facial iD Plating System

Indications for Use (Describe)

The Stryker Facial iD Plating System is intented for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).

Specific Indications for Use:

-Orthognathic surgery

-Reconstructive maxillofacial surgery

-Mandible and maxillofacial trauma surgery.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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"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."

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# K182305

# 510(k) Summary

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## 510(k) Summary

This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.

- I. SUBMITTER
510(k) Owner: Stryker Leibinger GmbH& Co. KG Boetzinger Strasse 41 D-79111 Freiburg, Germany Submitter/ Contact Zainab Amini Regulatory Affairs Specialist Person: Stryker Craniomaxillofacial 750 Trade Centre Way

> Portage, MI 49002 Phone: [phone] Fax: [phone]

- January 3rd, 2019 Date prepared:
- DEVICE II.
- Trade Name: Stryker Facial iD Plating System
- Common or Usual Bone Plating System name: Classification Bone Plate; 21 CFR §872.4760 name:
- Regulatory Class: Class II
- Product Code: JEY

#### III. PREDICATE DEVICE

Primary Predicate: K170272, TruMatch CMF Titanium 3D Printed Implant System.

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#### SUBJECT DEVICE DESCRIPTION IV.

The Stryker Facial iD Plating System (Subject Device) is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orthognathic surgery, reconstructive maxillofacial surgery, and mandible and maxillofacial trauma surgery.

The Subject Device plate(s) are additively manufactured patient-specific plates, and the patientspecific design of the plates allows certain features to be configured to meet the individual needs of each patient. The Subject Device plate(s) are provided with a printed version of the surgeonapproved Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Model. Additionally, the Subject Device is compatible with a separately provided Marking / Cutting Guide accessory.

| Application independent envelope attributes | |
|-----------------------------------------------------------------|--------------------------------------------------------------------------|
| Plate Material | Commercially pure titanium |
| Type of design | Patient specific |
| Ranges of shapes | Straight, L-plate, Y-plate, Interconnected combinations of the<br>above. |
| Range of length | 20 mm maximum bar length |
| Midface applications (Orthognathics, Trauma and Reconstruction) | |
| Screw systems | 1.7 mm, 2.0 mm MP |
| Plate profile height | 0.8 mm – 1.5 mm |
| Bar widths | 2.5 mm – 4.5 mm |
| Mandible applications (Orthognathics and Trauma) | |
| Screw systems | 2.0 mm, 2.0 mm MP |
| Plate profile height | 1.2 mm – 1.7 mm |
| Bar widths | 3.0 mm – 7.25 mm |
| Chin applications (Orthognathics) | |
| Screw systems | 1.7 mm, 2.0 mm MP |
| Plate profile height | 0.8 mm – 1.7 mm |
| Bar widths | 2.5 mm – 4.5 mm |

The Facial iD Plating Systems contains the following applications and design options:

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#### V. Reference Devices:

#### K022185, Stryker Universal CMF System

The Stryker Universal CMF System is intended for osteotomy, stabilization, and rigid fixation of craniomaxillofacial fractures and reconstruction. The Universal CMF System consists of an implant module for the respective anatomical and indicated areas with each containing various screw, and plate versions and shapes. These plates can be modified with bending instruments, such as cutters and benders, for an anatomical fit. The plates are attached to the bone with screws from the Stryker Universal CMF System. The Stryker Universal CMF System was cleared in K022185 and serves as the Reference Device for the Subject Device, as the Subject Device performance testing is in comparison to this Reference Device to make a substantial equivalence determination.

#### K132519, Stryker Customized Mandible Recon Plate Kit

The CMRP Kit (CMRP) is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions and is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction. The CMRP was cleared in K132519 and serves as a similar cleared Reference Device as well, which shows a similar implant design software and design process, shows implant compatibility with the anatomical model, and the utilization of customized marking / cutting and drill Guides which are similar to those offered for use with the Subject Device Stryker Facial iD Plating System.

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| TABLE 1: COMPARISON OF INDICATIONS FOR USE | | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device |
| | The Stryker Facial iD Plating System is<br>intended for osteotomy, stabilization and<br>rigid fixation of maxillofacial fractures<br>and reconstruction in adults and<br>adolescents (age 12 and higher). | The TruMatch CMF Titanium 3D<br>Printed Implant System is intended<br>for bone repositioning, fixation and<br>reconstruction of the maxillofacial<br>skeleton, midface, mandible and chin<br>in adolescents (greater than 12 to 21<br>years of age) and adults. |
| Indications for Use | Specific Indications for Use: | Specific Indications for Use: |
| | -Orthognathic surgery | -Orthognathic surgery |
| | -Reconstructive maxillofacial surgery | -Reconstructive mandible and<br>maxillofacial surgery |
| | -Mandible and maxillofacial trauma<br>surgery. | -Mandible and maxillofacial trauma<br>surgery. |

#### VI. INDICATIONS FOR USE

The overall Intended Uses of the Subject Device and Predicate Device are identical. The specific Indications for Use of the Subject Device and Predicate Device is similar, however, the slight difference in Indication for Use between the Subject Device and the Predicate Device does not constitute a new intended use, and does not raise any questions of safety and effectiveness. Therefore, substantial equivalence is shown between the Subject Device and Predicate Devices.

## VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Subject Device is compared to the Predicate Device for substantial equivalence of technological characteristics based on the following criteria:

- A. Principle of Operation
- B. Technological Characteristics

## A. Principle of Operation

The operating principle for the Subject Device is to reconstruct, stabilize and/or provide rigid fixation in the maxillofacial anatomy.

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#### B. Technological Characteristics

The fixation method, material, non-sterilization method, patient-specific offering, plate design including the guides and accessories are similar when comparing the Subject and Predicate Device. While the operating principle, fixation method, materility and sterilization method (minus the additive manufacturing and patient-specific designs for the Reference Device, K022185) are identical when comparing the Subject and Stryker Universal CMF Reference Device. The Subject Device performance testing was done in comparison to the Reference Device to demonstrate substantial equivalence.

| Feature | Subject Device | Primary Predicate Device -<br>TruMatch System | Explanation of<br>Differences |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Principle of Operation | The principle of operation for<br>the Subject Device is to<br>reconstruct, stabilize and/or<br>provide rigid fixation in the<br>maxillofacial anatomy. | The principle of operation for<br>the Predicate Device is to<br>reconstruct, stabilize and/or<br>provide rigid fixation in the<br>maxillofacial anatomy. | Similar |
| Fixation Method | Stryker Universal CMF<br>Screw Systems | Synthes Screw System | Similar |
| Material | commercially pure titanium | commercially pure titanium | Similar |
| Manufacturing Method | Additive | Additive | Similar |
| Sterilization Method | Moist Heat | Moist Heat | Similar |
| Provided Sterile | No | No | Similar |
| Patient-Specific<br>Configuration | Yes | Yes | Similar |

Table 12-2: Technological Characteristics Comparison

Reference Devices: K022185 (Stryker Universal CMF System) serves as a Reference Device for performance testing comparison to the Subject Device. K132519 (Stryker Customized Mandible Recon Plate Kit (CMRP)) serves as a Reference Device to the Subject Device for the implant design software and design process, implant compatibility with the anatomical models, and the utilization of the customized marking/cutting and drilling Guides.

## VIII. PERFORMANCE DATA

The following performance tests were performed in support of the substantial equivalence determination:

510(k) Summary K182305 - Stryker

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Table 2: This table provides a summary of the testing in comparison to the Reference Devices and non-clinical performance testing.

| Performance Testing Overview and Applicable Standards | | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test | Standard (testing method) | Results |
| Sterilization | ISO 17665-1 - Sterilization of health care<br>products - Moist heat - Part 1:<br>Requirements for the development,<br>validation and routine control of a<br>sterilization process for medical devices<br>ISO 14937 -Medical devices -<br>Sterilization of health care products -<br>General requirements for characterization<br>of a sterilization agent and the<br>development, validation and routine<br>control of a sterilization process for<br>medical devise. | The results of the steam<br>sterilization validation<br>show that the implants,<br>accessories and models<br>can be sterilized to a SAL of<br>10E-6 using the<br>recommended steam<br>sterilization instructions |
| Biocompatibility | FDA guidance “Use of International Standard ISO- 10993-1, "Biological<br>Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk<br>management process”, issued June 16, 2016 | |
| | Cytotoxicity<br>DIN EN ISO 10993-5 – Biological<br>evaluation of medical devices - Part 5:<br>Tests for in vitro cytotoxicity | Test results indicated no<br>cytotoxic effect. |
| | Sensitization and Intra-cutaneous<br>reactivity<br>ISO 10993-10: Tests for irritation and<br>delayed type<br>hypersensitivity – Kligman Maximization<br>test | in compliance with<br>requirements of the ISO<br>10993-10 guidelines |
| | Systemic toxicity<br>ISO 10993-11: Tests for systemic toxicity<br>Systemic injection test | in compliance with<br>requirements of the ISO<br>10993-11 guidelines |
| | Assessment of allowable limits for<br>leachable substances<br>ISO 10993-17 (2009) “Biological | - no toxicological concern<br>remains<br>- further biological testing are<br>considered not<br>justified |
| | medical devices — Part 17: Establishment<br>of<br>allowable limits for leachable substances”<br>Chemical characterization | chemical characterization as per report |
| | ISO 10993-18 - Biological evaluation of<br>medical devices - Part 18: Chemical<br>characterization of materials | |
| Mechanical | ASTM F382 – Standard specifications<br>and test method for metallic bone plates | Test results indicated the<br>subject device have higher<br>static bending strength and<br>has non-inferior fatigue<br>bending properties compared<br>to the reference device. |
| | ASTM STP 731 - Tables for estimating<br>median fatigue limit | |
| Cleaning<br>Validation | ANSI/AAMI TRI 30 - A compendium of<br>processes, materials, test methods, and<br>acceptance criteria for cleaning reusable<br>medical devices | Test results indicated that the<br>subject device is safe to be<br>cleaned as per the<br>recommended cleaning<br>instructions. |
| | ASTM E2314 - Standard Test Method for<br>Determination of Effectiveness of<br>Cleaning Processes for Reusable Medical<br>Instruments Using a Microbiologic<br>Method (Simulated Use Test) | |
| Transportation<br>Validation | ASTM D642 - Standard Test Method for<br>Determining Compressive Resistance of<br>Shipping Containers, Components, and<br>Unit Loads | Test results indicated that the<br>subject device is safe to be<br>shipped as per the<br>recommended shipping<br>instruction. |
| | ASTM F1886M - Standard Test Method<br>for Determining Integrity of Seals for<br>Flexible Packaging by Visual Inspection | |
| Compatibility<br>Testing | Combination of user need<br>validation lab and engineering<br>rationale | The subject device is<br>compatible<br>with the Stryker Universal<br>fixation system. |

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#### Performance Bench Testing

As stated above, mechanical strength testing was performed on the Subject Device plate(s). The mechanical strength testing results are included within this submission. The Subject Device met all pre-defined acceptance criteria, and the results of the tests support the substantial equivalence of the Subject Device to the Predicate Device, and to the reference devices

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#### Software output validation

An output validation of the entire software workflow including data transfer, imaging (CT and CBCT), bone model generation, plate design and additive manufacturing data preparation is included within this submission. The Subject Device met all pre-defined acceptance criteria, and the results of the validation support the substantial equivalence of the Subject Device to the Predicate Device, and to the reference devices.

#### Animal Testing

Animal testing was not required as a basis for substantial equivalence.

#### Clinical Testing

Clinical testing was not required as a basis for substantial equivalence.

#### IX. CONCLUSIONS

The results of the performance tests demonstrate that the Subject Device will perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence of the Subject Device to the Predicate Device, and to the reference devices.