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 Description

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.

AI/ML Overview

The provided document describes the Stryker Facial iD Plating System, a custom-designed maxillofacial plating system. The following information is extracted regarding its acceptance criteria and the studies performed:

Table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria (Standard / Description)	Reported Device Performance
Sterilization	ISO 17665-1: Requirements for the development, validation, and routine control of a sterilization process for medical devices (Moist Heat)ISO 14937: General requirements for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices	The results of the steam sterilization validation show that the implants, accessories, and models can be sterilized to a Sterility Assurance Level (SAL) of 10E-6 using the recommended steam sterilization instructions.
Biocompatibility	FDA guidance “Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process” (June 16, 2016)DIN EN ISO 10993-5: Tests for in vitro cytotoxicityISO 10993-10: Tests for irritation and delayed type hypersensitivity – Kligman Maximization testISO 10993-11: Tests for systemic toxicity – Systemic injection testISO 10993-17: Establishment of allowable limits for leachable substancesISO 10993-18: Chemical characterization of materials	Cytotoxicity: No cytotoxic effect.Sensitization and Intra-cutaneous reactivity: In compliance with ISO 10993-10 guidelines.Systemic toxicity: In compliance with ISO 10993-11 guidelines.Assessment of allowable limits for leachable substances: No toxicological concern remains; further biological testing not justified.Chemical characterization: Per report.
Mechanical Strength	ASTM F382: Standard specifications and test method for metallic bone platesASTM STP 731: Tables for estimating median fatigue limit	The subject device has higher static bending strength and non-inferior fatigue bending properties compared to the reference device.
Cleaning Validation	ANSI/AAMI TRI 30: Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devicesASTM E2314: Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)	The subject device is safe to be cleaned as per the recommended cleaning instructions.
Transportation Validation	ASTM D642: Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit LoadsASTM F1886M: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection	The subject device is safe to be shipped as per the recommended shipping instruction.
Compatibility Testing	User need validation lab and engineering rationale	The subject device is compatible with the Stryker Universal fixation system.
Software Output Validation	Pre-defined acceptance criteria for the entire software workflow (data transfer, imaging (CT and CBCT), bone model generation, plate design, and additive manufacturing data preparation)	The subject device met all pre-defined acceptance criteria, supporting its substantial equivalence.

Sample size used for the test set and the data provenance:
The document focuses on bench testing and validation studies, not clinical studies involving patient data. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as typically applied to AI/diagnostic device studies using patient data are not directly applicable here. The "test sets" refer to physical samples (e.g., plates, accessory models) used in engineering and biocompatibility tests. The number of samples for each specific test is not detailed, but it is implied that sufficient samples were tested to meet the respective standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the studies described are bench tests and validation studies for a medical device (bone plate system), not a diagnostic AI device requiring expert-established ground truth from patient data. The "ground truth" for these tests are the established standards and specifications (e.g., ISO, ASTM).
Adjudication method for the test set:
Not applicable, as no human expert adjudication of patient cases or images is described. The results of the tests were evaluated against predefined standards and criteria.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not performed. This document describes the clearance of a physical medical device (bone plating system), not an AI/diagnostic software.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
While "Software output validation" was conducted for the design and manufacturing workflow, this is not a standalone performance evaluation of a diagnostic or assistive AI algorithm in the typical sense. It validates the output of the design software, ensuring it accurately translates digital models to manufacturing data. There's no performance metric comparing the algorithm's output to a ground truth established by humans for diagnostic purposes.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For bench testing and validation, the ground truth is based on:
- Established engineering standards: e.g., ASTM F382 for metallic bone plates, ASTM STP 731 for fatigue limits, ASTM D642 for compressive resistance, ASTM F1886M for seal integrity, ASTM E2314 for cleaning effectiveness.
- Biocompatibility standards: e.g., ISO 10993 series and FDA guidance.
- Sterilization standards: e.g., ISO 17665-1, ISO 14937.
- Internal design specifications and user requirements: For software output validation and compatibility testing.
The sample size for the training set:
Not applicable. This device is a physical bone plating system, not an AI model that requires a training set of data. The "patient-specific design" does involve software to design the plates for individual patients, but this is a design workflow, not a machine learning model that learns from a training set in the conventional sense.
How the ground truth for the training set was established:
Not applicable, as there is no mention of a "training set" for an AI model in this 510(k) submission.

Summary

{0}------------------------------------------------

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

{1}------------------------------------------------

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 (1-800-638-2041 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

{2}------------------------------------------------

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

{3}------------------------------------------------

K182305

510(k) Summary

{4}------------------------------------------------

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: 269-389-8349 Fax: 877-648-7114

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.

{5}------------------------------------------------

SUBJECT DEVICE DESCRIPTION IV.

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 theabove.
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:

{6}------------------------------------------------

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.

{7}------------------------------------------------

TABLE 1: COMPARISON OF INDICATIONS FOR USE
	Subject Device	Predicate Device
	The Stryker Facial iD Plating System isintended for osteotomy, stabilization andrigid fixation of maxillofacial fracturesand reconstruction in adults andadolescents (age 12 and higher).	The TruMatch CMF Titanium 3DPrinted Implant System is intendedfor bone repositioning, fixation andreconstruction of the maxillofacialskeleton, midface, mandible and chinin adolescents (greater than 12 to 21years of age) and adults.
Indications for Use	Specific Indications for Use:	Specific Indications for Use:
	-Orthognathic surgery	-Orthognathic surgery
	-Reconstructive maxillofacial surgery	-Reconstructive mandible andmaxillofacial surgery
	-Mandible and maxillofacial traumasurgery.	-Mandible and maxillofacial traumasurgery.

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.

{8}------------------------------------------------

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 -TruMatch System	Explanation ofDifferences
Principle of Operation	The principle of operation forthe Subject Device is toreconstruct, stabilize and/orprovide rigid fixation in themaxillofacial anatomy.	The principle of operation forthe Predicate Device is toreconstruct, stabilize and/orprovide rigid fixation in themaxillofacial anatomy.	Similar
Fixation Method	Stryker Universal CMFScrew 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-SpecificConfiguration	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

{9}------------------------------------------------

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 careproducts - Moist heat - Part 1:Requirements for the development,validation and routine control of asterilization process for medical devicesISO 14937 -Medical devices -Sterilization of health care products -General requirements for characterizationof a sterilization agent and thedevelopment, validation and routinecontrol of a sterilization process formedical devise.	The results of the steamsterilization validationshow that the implants,accessories and modelscan be sterilized to a SAL of10E-6 using therecommended steamsterilization instructions
Biocompatibility	FDA guidance “Use of International Standard ISO- 10993-1, "BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing within a riskmanagement process”, issued June 16, 2016
	CytotoxicityDIN EN ISO 10993-5 – Biologicalevaluation of medical devices - Part 5:Tests for in vitro cytotoxicity	Test results indicated nocytotoxic effect.
	Sensitization and Intra-cutaneousreactivityISO 10993-10: Tests for irritation anddelayed typehypersensitivity – Kligman Maximizationtest	in compliance withrequirements of the ISO10993-10 guidelines
	Systemic toxicityISO 10993-11: Tests for systemic toxicitySystemic injection test	in compliance withrequirements of the ISO10993-11 guidelines
	Assessment of allowable limits forleachable substancesISO 10993-17 (2009) “Biological	- no toxicological concernremains- further biological testing areconsidered notjustified
	medical devices — Part 17: Establishmentofallowable limits for leachable substances”Chemical characterization	chemical characterization as per report
	ISO 10993-18 - Biological evaluation ofmedical devices - Part 18: Chemicalcharacterization of materials
Mechanical	ASTM F382 – Standard specificationsand test method for metallic bone plates	Test results indicated thesubject device have higherstatic bending strength andhas non-inferior fatiguebending properties comparedto the reference device.
	ASTM STP 731 - Tables for estimatingmedian fatigue limit
CleaningValidation	ANSI/AAMI TRI 30 - A compendium ofprocesses, materials, test methods, andacceptance criteria for cleaning reusablemedical devices	Test results indicated that thesubject device is safe to becleaned as per therecommended cleaninginstructions.
	ASTM E2314 - Standard Test Method forDetermination of Effectiveness ofCleaning Processes for Reusable MedicalInstruments Using a MicrobiologicMethod (Simulated Use Test)
TransportationValidation	ASTM D642 - Standard Test Method forDetermining Compressive Resistance ofShipping Containers, Components, andUnit Loads	Test results indicated that thesubject device is safe to beshipped as per therecommended shippinginstruction.
	ASTM F1886M - Standard Test Methodfor Determining Integrity of Seals forFlexible Packaging by Visual Inspection
CompatibilityTesting	Combination of user needvalidation lab and engineeringrationale	The subject device iscompatiblewith the Stryker Universalfixation system.

{10}------------------------------------------------

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

{11}------------------------------------------------

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.

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
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.(b)
Classification. Class II.