The Universal Mesh is indicated for reconstruction, stabilization subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).

Device Description

The Stryker Universal Mesh consists of mesh implants in different shapes, thicknesses and perforation patterns which include the 1.2mm and 1.5/ 1.7mm Dynamic Mesh implants and Hybrid Mesh implants. The meshes can be modified with trimming and bending instruments for an anatomical fit and are malleable for three-dimensional adaptations. The necessary instrumentation for mesh modification, Mesh Cutter (coarse), Mesh Step Bender, and the Mesh Clipper are included with the system. The Stryker Universal Mesh implants are provided nonsterile and are for single use only. The instrumentation and storage system is reusable.

Also, the mesh can be fixated to the bone with screws available in previously marketed Stryker CMF implant systems. The previously marketed screws are not specifically packaged with the subject device, but the implant tray of the Universal Mesh Storage system contains space to store the screw disc if that option is chosen.

AI/ML Overview

The provided document describes the Stryker Universal Mesh, a cranioplasty plate, and its substantial equivalence determination by the FDA. However, the document does not contain information related to an AI/ML device. Therefore, it does not include studies with acceptance criteria for device performance, sample sizes for test or training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

The document focuses on non-clinical performance testing for a medical device (cranioplasty plate) made of titanium, assessing its biocompatibility, reprocessing, cleaning, sterilization, mechanical performance, corrosion, and MR compatibility. These tests are standard for a physical medical device and do not involve AI/ML.

Given the absence of information regarding an AI/ML device, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML context.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 8, 2016

Stryker Craniomaxillofacial Mr. Jonathan Schell Sr. Regulatory Affairs Specialist 750 Trade Centre Way, Suite 200 Portage, MI 49002

Re: K161821

Trade/Device Name: Stryker Universal Mesh Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO Dated: November 4, 2016 Received: November 7, 2016

Dear Mr. Schell:

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 (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.

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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 at its toll-free number (800) 638-2041 or (301) 796-7100 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

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) K161821

Device Name Stryker Universal Mesh

Indications for Use (Describe)

The Universal Mesh is indicated for reconstruction, stabilization subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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.

SUBMITTER [§807.92(a)(1)] I.

510(k) Owner:	Stryker Leibinger GmbH & Co. KG
	Boetzinger Strasse 41
	79111 Freiburg, Germany

Submitter/ Contact Jonathan Schell Person: Sr. Regulatory Affairs Specialist Stryker Craniomaxillofacial 750 Trade Centre Way Portage, MI 49002 Phone: 269-389-5596 Fax: 877-648-7114
Date prepared: November 4, 2016

II. DEVICE [§807.92(a)(2)]

Trade Name:	Stryker Universal Mesh
Common or Usualname:	Bone Plate
Classificationname:	Preformed Alterable Cranioplasty Plate; 21 CFR 882.5320
Regulatory Class:	Class II
Product Code:	GWO
ClassificationPanel:	Neurology

PREDICATE DEVICE [§807.92(a)(3)] III.

Universal CMF System – K022185

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IV. DEVICE DESCRIPTION [§807.92(a)(4)]

INDICATIONS FOR USE [§807.92(a)(5 )] V.

	Subject Device	Predicate - K022185
Indications forUse	The Universal Mesh is indicated forreconstruction, stabilization and/orrigid fixation subsequent tocraniotomy, craniectomy,cranioplasty, and cranial fractures inadults and adolescents (age 12 andhigher).	The Stryker Leibinger UniversalCMF System is a Cranio-maxillofacial (CMF) plate and screwsystem intended for osteotomy,stabilization and rigid fixation ofCMF fractures and reconstruction.

TABLE 1: COMPARISON OF INDICATIONS FOR USE

The predicate device is indicated for use in a range of anatomic areas (cranial, craniofacial skeleton, mid-face, maxilla, mandible) for a variety of surgical applications (craniofacial surgery, reconstructive procedures). The Indications for Use statement of the Stryker Universal Mesh falls within the scope of the broader Indications statement of the predicate device. Additionally, the Subject device is intended to be used in adolescent patients 12 years of age and older. The differences in the Indications statement for the proposed device in comparison to the predicate does not constitute a new intended use.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE [§807.92(a)(6)]

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The Stryker Universal Mesh is compared to its predicate devices for substantial equivalence based on the following criteria:

A. Principle of Operation
B. Technological Characteristics

A. Principle of Operation

The Stryker Universal Mesh implants are designed for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. The necessary instrumentation and product storage are included with the system.

B. Technological and Operational Characteristics

-Substantial Equivalence of the Subject devices and Predicate devices are based on the following technological elements:

Feature	Stryker Universal Mesh	Universal CMF SystemK022185	Explanation of Differences
	Subject Device	Predicate Device
Sterility: EndUser Sterilized	X	X	Same
Sizing
Shape	Square, partly with rounded edges	Square	Similar
Sizes	40x40mmto200x200mm	40x40mmto200x200m	Similar
ImplantThickness	0.3mm -0.8mm	0.3mm -0.6mm	Similar
Design
2-dimensional(2D)	X	X	Same
Mode ofFixation
1.2mm - 1.7mmscrews	X	X	Same
Material
Titanium:Commerciallypure titaniumASTM F67	X	X	Same

Overall these changes do not alter the Subject device significantly and it does not represent a new worst case in design.

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VII. PERFORMANCE DATA [§807.92(b)(1)]

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the Stryker Universal Mesh system was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The tests supported the biocompatibility of the device.

The implant is made from titanium which conforms to ASTM F67 for chemical composition, the same as the predicate. Cytotoxicity testing was performed using DIN EN 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. Chemical residual analysis was conducted according to validated methods with results that met the established acceptance criteria. These tests support the biocompatibility of the device.

Performance Testing

Test	Test Method Summary	Results
Life timereprocessing	Verify the reprocessing life of the Subject device, instruments, and storagecontainer are according to internal standard.	Internal AcceptanceCriteria
CleaningValidation	Verify the cleaning process for Subject device, instruments and storagecontainer are according to recommendations in ISO 17664, AAMI TIR 30,and AAMI TIR 12.	Method validated.
SterilizationValidation	Validate the sterilization instructions for the Subject device, instruments,and storage container are according to internal standard. Referencedstandards: ISO 14937, ISO 17664, ISO 17665 - 1&2, AAMI TIR 12,AAMI ST 81, AAMI ST79.	Method validated.
MechanicalperformanceTesting	Static Load Test and Dynamic Load Test	Acceptance criterionwere met, tests werepassed.
CorrosionTesting	Verify corrosion behavior of Subject device, instruments, and storagedevice.	Acceptance criterionwas met, test waspassed.
MRCompatibility	Magnetic Resonance (MR) testing was performed on the subject devicemesh implants in accordance with FDA draft guidance for industry"Assessment of Radiofrequency - Induced Heating in the MagneticResonance (MR) Environment for Multi-Configuration Passive Medical	Based on the results ofthese evaluations, theStryker Universal meshwill be labeled as MR

The following performance tests were completed:

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Devices," June 29, 2015. MR heat testing has been performed on theSubject device according to FDA final guidance "Establishing Safety andCompatibility of Passive Implants in the Magnetic Resonance (MR)Environment," December 11, 2014.	conditional.
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The Subject device met all pre-defined acceptance criteria and standards and was found to not represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device.

Animal Testing

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

Clinical Testing [§807.92(b)(2)]

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

VIII. CONCLUSIONS [§807.92(b)(3)]

The results of the non-clinical data demonstrate the Stryker Universal Mesh will perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.92 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).