Stryker Surgeon iD Mandible Recon Plate

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" appearing in a smaller font size below. June 28, 2019 Stryker Zainab Amini Regulatory Affairs Specialist 750 Trade Centre Way - Suite 200 Portage, Michigan 49002 Re: K190696 Trade/Device Name: Stryker Surgeon iD Mandible Recon Plate Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: May 29, 2019 Received: May 30, 2019 #### 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. {1}------------------------------------------------ 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 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 Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190696 Device Name Stryker Surgeon iD Mandible Recon Plate Indications for Use (Describe) The Stryker Surgeon iD Mandible Recon Plate is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions. The Stryker Surgeon iD Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # 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 [§807.92(a)(1)] I. - 510(k) Owner: Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 79111 Freiburg, Germany - Submitter/ Zainab Amini Contact Person: Regulatory Affairs Specialist Stryker Craniomaxillofacial 750 Trade Centre Way Portage, MI 49002 Phone: 269-389-8349 Fax: 877-648-7114 - Date prepared: June 28, 2019 - DEVICE [§807.92(a)(2)] II. | Trade Name: | Stryker Surgeon iD Mandible Recon Plate | | |--------------------------|-----------------------------------------|--| | Common or<br>Usual name: | Bone Plate | | | Classification<br>name: | Bone Plate, 21 CFR §872.4760 | | | Regulatory<br>Class: | Class II | | | Product Code: | JEY | | #### PREDICATE DEVICE [§807.92(a)(3)] III. Predicate: Stryker Customized Mandible Recon Plate Kit - K132519 {4}------------------------------------------------ #### DEVICE DESCRIPTION [§807.92(a)(4)] IV. The Subject Device, the Stryker Surgeon iD Mandible Recon Plate is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions. The Surgeon iD Mandible Recon Plate is a surgeon-specific plate which is designed based on an average mandible model. The plate is designed per surgeon's preference within the following design envelope. The Surgeon iD Mandible Recon Plate is offered in hemi and full shapes and three different sizes (Small, Medium, and Large). The plate can be designed with a profile height of 2.0 mm or 2.8 mm, with a number of screw holes between 4 and 50, and bar widths between 5.5 mm and 6.5 mm. The plate is made of commercially pure titanium. - V. REFERENCE DEVICE K014263, Stryker Universal Mandible System The Stryker Universal Mandible System is intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction and cleared in K014263. The Reference Device and the Subject Device has similar fixation system and accessories and therefore, serves as the Reference Device for this submission. #### INDICATIONS FOR USE [§807.92(a)(5 )] VI. #### TABLE 1 SUBJECT AND PREDICATE DEVICE'S INDICATION FOR USE. | | Subject Device: Stryker Surgeon iD<br>Mandible Recon Plate (SMRP) | Predicate Device: Stryker<br>Customized Mandible Recon Plate<br>(CMRP), K132519 | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use/<br>Indication<br>for Use | The Stryker Surgeon iD Mandible<br>Recon Plate is intended to be used<br>for rigid internal fixation of primary<br>and secondary mandibular<br>reconstructions. | The Customized Mandible Recon<br>Plate Kit is intended to be used for<br>rigid internal fixation of primary<br>and secondary mandibular<br>reconstructions. | | | The Stryker Surgeon iD Mandible<br>Recon Plate is indicated for use in<br>primary mandibular reconstruction<br>with bone graft, temporary bridging<br>until delayed secondary<br>reconstruction and secondary<br>mandibular reconstruction. | The Customized Mandible Recon<br>Plate Kit is indicated for use in<br>primary mandibular reconstruction<br>with bone graft, temporary bridging<br>until delayed secondary<br>reconstruction and secondary<br>mandibular reconstruction. | {5}------------------------------------------------ # VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [§807.92(a)(6)] The Subject Device has an identical principle of operation, and technological characteristics as the Predicate Device. However, the Subject Device Surgeon iD Mandible Recon Plate is surgeon-specific, the plates are designed per surgeon's preferences and offered in three sizes (Small, Medium, and Large). The plates may be modified intra-operatively to fit a specific patient's anatomy (e.g., by cutting or bending). The Subject Device Stryker Surgeon iD Mandible Recon Plate is based on the following criteria: - A. Principle of Operation - B. Technological Characteristics ### A. Principle of Operation The basic operational principle of the Subject and the Predicate Device is rigid internal fixation of primary and secondary mandibular reconstructions. # B. Technological and Operational Characteristics The technological and operational characteristics of the Subject and the Predicate Device is to reconstruction or bridging of mandible resection, and area of the application is mandible. # VIII. PERFORMANCE DATA [§807.92(b)(1)] The Subject Device is equivalent to the Predicate Device for cleaning and sterilization validation, the Subject Device's biocompatibility testing and sterilizations are referenced in the Predicate Device. ### Performance Bench Testing Verification and Validation activities were assessed on the Subject Device Surgeon iD Mandible Recon Plate, the V&V activities are referenced in the Predicate Device and Reference Device. Additionally, the following performance testing were completed for the Subject Device: - Analysis of Functional Interfaces - - -Evaluation of the Models - Compatibility - - -Packaging The results of the activities showed that the Subject Device met all pre-defined acceptance criteria. Therefore, the Subject Device is substantially equivalent to the Predicate and Reference Devices. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the text "K190696" on the top line and the word "stryker" on the second line. The word "stryker" is in a bold, sans-serif font. The text is black and the background is white. ### 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. ### IX. CONCLUSIONS [§807.92(b)(3)] The results of the non-clinical data demonstrate the Subject Device 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.