The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects, including, but not limited to, the correction and prevention of persistent temporal hollowing (PTH).

Device Description

The Stryker CMF MEDPOR Customized Implant, also referred to as MEDPOR CIs, product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input. These MEDPOR CIs are currently packaged into MEDPOR CI Kits with a patient-specific Host Bone Model (HBM) that represents the 3D patient's anatomy surrounding the defect location. This Special 510(k) is submitted specifically to include the customer option to sell new Stryker CMF MEDPOR Priority Customized Implant Kits without the Host Bone Model subcomponent.

AI/ML Overview

The Stryker CMF MEDPOR Priority Customized Implant Kit is a medical device that has been cleared by the FDA. The device is intended for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Standard	Reported Device Performance	Study Details
Sterilization	Product Adoption Protocol	Passed	Testing performed to adopt the MEDPOR Priority CI Kit into existing Cycle 51 at Stryker Sustainability Solutions.
Sterilization / Biocompatibility	EO Residual Testing	Passed	Evaluated ethylene oxide (EO) residuals to ensure biocompatibility after sterilization by Stryker Sustainability Solutions.
Design Integrity	No change to the MEDPOR CI device itself	Confirmed no changes to the implant design.	This submission is specifically for the optional removal of the Host Bone Model subcomponent, not the implant itself.
Material Integrity	No change in materials of construction	Confirmed implants are still made from high-density polyethylene (HDPE).	Comparative review with predicate device (K153508).
Manufacturing Process Integrity	No change in manufacturing process	Confirmed manufacturing process for the implant itself remains the same.	Comparative review with predicate device (K153508).
Duration/Location of Contact	No change in duration or location of contact	Confirmed no changes.	Comparative review with predicate device (K153508).
Intended Use	Same as predicate device	Confirmed same intended use.	The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation and/or restoration of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects, including, but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
Operating Principle	Same as predicate device	Confirmed same operating principle.	To fill bony voids, defects, and contour irregularities in non-load bearing regions of the craniofacial skeleton.
Mode of Fixation	Same as predicate device	Confirmed implants are fixated with Stryker Neuro, Midface, and/or Upperface self-drilling screws.	Comparative review with predicate device (K153508).
Safety and Effectiveness	Modifications do not raise new questions of safety or effectiveness.	Concluded that the modifications support substantial equivalence.	A risk analysis was performed. Performance bench testing, animal testing, and clinical testing were not required as a basis for substantial equivalence because the core device design and materials remained unchanged.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a separate "test set" in the traditional sense for evaluating device performance. The evaluation was primarily a comparison to a predicate device and focused on changes related to sterilization with a new facility.

Sterilization Testing: The sample size for the "Product Adoption" and "EO Residual" testing is not explicitly stated. The text describes "tests were performed to adopt the MEDPOR Priority CI Kit into existing Cycle 51 at Stryker Sustainability Solutions." This implies samples of the MEDPOR CIs were used for these sterilization validation tests.
Data Provenance: The new sterilization location is Stryker Sustainability Solutions, so the data would originate from that facility's testing protocols. The nature of this testing (e.g., in-house lab testing for sterility assurance) is inherently prospective for the validation of the new sterilization site.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the context of this submission. The submission primarily addresses a change in offering (removal of a subcomponent) and validation of an additional sterilization location. It does not involve a diagnostic or interpretive device where "ground truth" would be established by experts reviewing a test set of cases. The ground truth for sterilization is established through established ISO standards and validation protocols for sterility assurance levels.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring multi-expert adjudication described for this submission. The validation focused on physical and chemical properties related to sterilization and ensuring consistency with the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical implant, not an AI-assisted diagnostic tool or an imaging system that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Stryker CMF MEDPOR Priority Customized Implant Kit is a physical implant, not an algorithm or software-based device.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Sterilization Standards: Industrial sterilization validation standards (likely ISO 11135 for Ethylene Oxide sterilization) serve as the ground truth for confirming product sterility and acceptable EO residuals.
Predicate Device Equivalence: The established physical, chemical, and biological properties of the previously cleared predicate device (K153508) serve as the ground truth for substantial equivalence, given that the core implant design, materials, and intended use have not changed.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI/ML-based device that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8)

Summary

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August 15, 2019

Stryker Leibinger GmbH & Co. KG Gregory Gohl Sr. Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg, D-79111 De

Re: K191916

Trade/Device Name: Stryker CMF MEDPOR Priority Customized Implant Kit Regulation Number: 21 CFR 878.3550 Regulation Name: Chin Prosthesis Regulatory Class: Class II Product Code: FWP Dated: July 16, 2019 Received: July 17, 2019

Dear Gregory Gohl:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Nina Mezu-Nwaba. PharmD.. MPH.. MSc. CAPT., United States Public Health Service Assistant Director (Acting), Plastic Surgery Implant Devices Team Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191916

Device Name

Stryker CMF MEDPOR Priority Customized Implant Kit

Indications for Use (Describe)

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

☑ 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.

I. SUBMITTER [§807.92(a)(1)]

510(k) Owner:	Stryker Leibinger GmbH& Co. KGBoetzinger Strasse 41D-79111 Freiburg, Germany
Submitter/ ContactPerson:	Gregory GohlSr. Regulatory Affairs SpecialistStryker Craniomaxillofacial (CMF)750 Trade Centre WayPortage, MI 49002Phone: 269-389-4319

Fax: 877-648-7114

Date prepared: July 16, 2019

DEVICE [§807.92(a)(2)] II.

Trade Name:	Stryker CMF MEDPOR Priority Customized Implant Kit
Abbreviated Name:	MEDPOR Priority CI Kit
Common or Usual Name:	Customized Implant
Device:	Prosthesis, Chin, Internal; per 21 CFR §878.3550
Classification Name &Regulation Description:	Chin prosthesis; per 21 CFR §878.3550
Regulation MedicalSpecialty & Review Panel:	General & Plastic Surgery
Product Code:	FWP
Regulatory Device Class:	Class II
*Note the company Stryker or legacy name Stryker Leibinger precedes theproduct/trade name and predicate device in some documentation.

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PREDICATE DEVICE [§807.92(a)(3)] III.

510(k) Number: K191916

Predicate Device: Stryker CMF MEDPOR Customized Implant (also referred to as MEDPOR CIs or MEDPOR CI Kits) - K153508

Reference Device: PEEK Customized Cranial Implant (CCI) Priority - K152076

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

The Stryker CMF MEDPOR Customized Implant, also referred to as MEDPOR CIs, product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input. These MEDPOR CIs are currently packaged into MEDPOR CI Kits witha patient-specific Host Bone Model (HBM) that represents the 3D patient's anatomy surrounding the defect location. This Special 510(k) is submitted specifically to include the customer option to sell new Stryker CMF MEDPOR Priority Customized Implant Kits without the Host Bone Model subcomponent.

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

	Subject Device	Predicate Device – K153508
Indications forUse	The Stryker CMF MEDPORCustomized Implant is indicated forthe augmentation and/or restorationof bony and/or soft tissue deformitiesin post-traumatic, post-surgical, orcongenital craniofacial defects,including, but not limited to, thecorrection and prevention ofpersistent temporal hollowing(PTH).	The Stryker CMF MEDPORCustomized Implant is indicated forthe augmentation and/or restoration ofbony and/or soft tissue deformities inpost-traumatic, post-surgical, orcongenital craniofacial defects,including, but not limited to, thecorrection and prevention of persistenttemporal hollowing (PTH).

TABLE 5-1: COMPARISON OF INDICATIONS FOR USE

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

The subject device is compared to its predicate device for substantial equivalence of technological characteristics based on the following criteria:

A. Principles of Operation
B. Technological Characteristics

A. Principles of Operation / Operating Principle

The basic operational principle of the Stryker CMF MEDPOR Customized Implant remains the same as the predicate: The MEDPOR CIs are intended to be used to fill bony voids, defects, and contour irregularities in non-load bearing regions of the craniofacial skeleton.

B. Technological Characteristics

The technological characteristics remain the same as the predicate:

Same Intended Use: The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation and/or restoration of bony and/or soft tissue deformities in posttraumatic, post-surgical, or congenital craniofacial defects, including, but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
-Same Operating Principle: to fill bony voids, defects, and contour irregularities in nonload bearing regions of the cranial skeleton.
Same Mode of Fixation: fixated to the native bone with Stryker Neuro. Midface, and/or -Upperface self-drilling screws.
Same Materials of Construction: Implants are made from high density polyethylene -(HDPE).
Same Design: the customized craniofacial implants are molded from HDPE to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request.

VII. PERFORMANCE DATA [§807.92(b)(7)]

The modifications described in this submission is the optional removal of the Host Bone Model subcomponent from the Stryker CMF MEDPOR Customized Implant Kit. This introduces a new product offering called the Stryker CMF MEDPOR Priority Customized Implant Kit, also referred to as the MEDPOR Priority CI Kit. There are no changes to the MEDPOR CI device itself.

Without the Host Bone Model in the MEDPOR Priority CI Kit, the necessity to gamma sterilize a subcomponent no longer exists. Therefore, Stryker Sustainability Solutions (SSS)

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Incorporated was identified and evaluated as an additional Ethylene Oxide (EO) sterilization location for MEDPOR CIs due to the location's ability to achieve a quicker turnaround time to the end-user. SSS was proven to be as safe and effective for sterilization as the predicate location (see Section 14 for sterilization evaluation and adoption).

A risk analysis was performed, and sterilization testing was performed in support of the substantial equivalence determination.

There is no change in the design, material, manufacturing process, or duration/location of contact. The only change necessary to evaluate by testing is the additional sterilization location for MEDPOR Cls. The tests were performed to adopt the MEDPOR Priority CI Kit into existing Cycle 51 at Stryker Sustainability Solutions.

Sterilization and Biocompatibility Testing

Characteristic	Test	Result
Sterilization	Product Adoption	Passed
Sterilization /Biocompatibility	EO Residual	Passed

Performance Bench Testing

Performance bench testing was not required as a basis for substantial equivalence.

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.

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VIII. CONCLUSIONS [§807.92(b)(3)]

In summary, the Stryker CMF MEDPOR Priority Customized Implant Kit is substantially equivalent to its predicate device. The fundamental scientific technology has not changed from the predicate device since the design of the Stryker CMF Customized Implant subcomponent has not changed. The only addition is to provide a MEDPOR Priority CI Kit with two identical sterile implants and no Host Bone Model in a suitable packaging system. The intended use, technological characteristics, and materials of construction have not changed as discussed in detail above and other sections of the submission. The modifications do not raise new questions of safety or effectiveness. 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.

Regulation Number and Section

§ 878.3550 Chin prosthesis.

(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.