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 (CI) product offerings provide customized craniofacial patient specific implants designed at the request of a surgeon. The customized craniofacial implants are molded from porous high density polyethylene (HDPE) and the MEDPOR material provides a porous structure which allows for tissue ingrowth. The MEDPOR CI is manufactured to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Stryker CMF MEDPOR Customized Implant." The purpose of this notification is to demonstrate that the device is substantially equivalent to a previously cleared predicate device.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, primarily through comparison of technological characteristics and indications for use, rather than presenting de novo performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because this information is not present in the provided document. The document explicitly states:

"Biocompatibility and sterility testing of the device is not required as a basis for substantial equivalence." (Page 5)
"Performance Bench testing was not required as a basis for substantial equivalence." (Page 5)
"Animal testing was not required as a basis for substantial equivalence." (Page 5)
"Clinical Testing: To support the inclusion of the PLUS design option, and the corresponding indication for use, Stryker has leveraged clinical literature and case history." (Page 6) - This indicates a literature review, not a new clinical study with acceptance criteria.

The document is a declaration of substantial equivalence, which often relies on demonstrating that a new device is "as safe and effective" as a legally marketed predicate device without requiring new performance data against specific acceptance criteria, especially if the changes are minor or relate to a new indication for a similar device.

Summary

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

February 5, 2016

Stryker Mr. Jonathan Schell Senior Regulatory Affairs Specialist 750 Trade Centre Way, Suite 200 Portage, Michigan 49002

Re: K153508

Trade/Device Name: Stryker CMF MEDPOR Customized Implant Regulation Number: 21 CFR 878.3550 Regulation Name: Chin Prosthesis Regulatory Class: Class II Product Code: FWP Dated: December 4, 2015 Received: December 7, 2015

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 yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153508

Device Name Stryker CMF MEDPOR Customized Implant

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 5. 510(k) Summary

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

SUBMITTER I.

510(k) Owner:	Stryker Leibinger GmbH& Co. KGBoetzinger Strasse 41D-79111 Freiburg, Germany
Submitter/ ContactPerson:	Jonathan SchellSr. Regulatory Affairs SpecialistStryker Craniomaxillofacial750 Trade Centre WayPortage, MI 49002Phone: 269-389-5596Fax: 877-648-7114
Date prepared:	December 4, 2015
II.	DEVICE
Trade Name:	Stryker MEDPOR Customized Implant
Common or Usualname:	Prosthesis, chin, internal
Classificationname:	Chin prosthesis, 21 CFR §878.3550
Regulatory Class:	Class II
Product Code:	FWP

PREDICATE DEVICE III.

Predicate: Stryker MEDPOR Customized Implant– K143173

This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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This traditional 510(k) is submitted to add an additional indication for use for the augmentation and/or restoration of ... soft tissue deformities in the cranial and craniofacial skeleton; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).

V. INDICATIONS FOR 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).

The MEDPOR CI PLUS has an additional indication for use which is not included in the Predicate device an added PLUS design option, but this difference does not constitute a new Intended Use. Both the MEDPOR CI PLUS and the predicate device have the same Intended Use to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton. Also, this difference does not alter the intended therapeutic use of the device nor does the difference affect the safety and effectiveness of the device relative to the predicate device.

A literature review was performed to identify relevant clinical literature with applicable data to show that, when compared to the predicate device, the new Indication for use added to the subject device does not raise new questions of safety or effectiveness. The results of this review provides evidence of this fact.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The MEDPOR CI PLUS is compared to its predicate device for substantial equivalence based on the following criteria:

A. Principle of Operation
B. Technological Characteristics

The only changes associated with the subject device design, relative to the predicate device, result from the additional indication for use. The additional indication for use corresponds to

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a contour design selection option during the ordering process, and enhanced surgeon input during the design process. The remaining technological characteristics of the subject device, when compared to the predicate device, are unchanged.

A. Principle of Operation

The basic operational principle of the MEDPOR CI PLUS remains the same as the predicate: the MEDPOR Customized Implant is intended to be used to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton.

B. Technological and Operational Characteristics

The addition of a new indication for use to the MEDPOR CI does not alter the technological characteristics of the actual customized cranial or craniofacial implant. The technological characteristics remain the same as the predicate:

Same operating principle: to fill bony voids, defects, and contour irregularities in non-load 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 material: 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

Biocompatibility Testing

Biocompatibility and sterility testing of the device is not required as a basis for substantial equivalence. There is no change in the material, duration or location of contact, or sterilization methods for the MEDPOR CI PLUS. The identical manufacturing processes and materials are used in both the subject and predicate device.

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

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To support the inclusion of the PLUS design option, and the corresponding indication for use, Stryker has leveraged clinical literature and case history. A summary of the clinical literature verifies that PTH reflects a deficiency in the bulk of the temporalis muscle or overlying temporal fat pad. Surgical results with augmented implant designs have been published upon and shown to be clinically successful in addressing PTH.

To that end, Stryker has incorporated surgeon design input into a customized implant with an augmented contour. In all patient-specific reconstructions, the level of implant augmentation may be adjusted based on surgeon clinical knowledge of the patient condition and the surgical approach. This culmination of surgeon input and approval and case history results in the CI PLUS, which has shown that the augmented contour of the CI PLUS counteracts the asymmetry observed in certain neurosurgical procedures.

VIII. CONCLUSIONS

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.