Stryker SternalPlate System

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March 5, 2019 Stryker Hans Geiger Senior Regulatory Affairs Specialist 750 Trade Centre Way, Suite 200 Portage, Michigan 49002 Re: K183172 Trade/Device Name: Stryker SternalPlate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: January 17, 2019 Received: January 22, 2019 Dear Mr. Geiger: 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, 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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, Laurence D. Coyne -S For Mark N. Melkerson Director Division of Orthopedic 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) K183172 Device Name Stryker SternalPlate System Indications for Use (Describe) The SternalPlate system is indicated for use in stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy, sternal fracture(s), and sternal reconstructive surgical procedures to promote bony fusion. 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}------------------------------------------------ # 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<br>Boetzinger Strasse 41<br>79111 Freiburg, Germany | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter/ Contact<br>Person: | Hans M. Geiger<br>Sr. Regulatory Affairs Specialist<br>Stryker Craniomaxillofacial<br>750 Trade Centre Way<br>Suite 200<br>Portage, MI 49002<br>Phone: 269-389-2323<br>Fax: 877-648-7114 | | Date prepared: | February 28, 2019 | - II. DEVICE [§807.92(a)(2)] | Trade Name: | Stryker SternalPlate System | |---------------------------------------|--------------------------------------------------------------------------------| | Common or Usual<br>name: | Bone Plate and Screws | | Classification<br>name: | Single/Multiple Component Metallic Bone Fixation Appliances and<br>Accessories | | Regulation<br>Number: | 21 CFR § 888.3030 | | Regulatory Class: | Class II | | Product Code: | HRS | | III. PREDICATE DEVICE [§807.92(a)(3)] | | Biomet Microfixation Sternal Closure System – K121302 This predicate has not been subject to a design-related recall. Traditional 510(k) {4}------------------------------------------------ # IV. DEVICE DESCRIPTION [§807.92(a)(4)] The Subject Device System contains various plates with different shapes which allow for intraoperative contouring and cutting of the plates as well as for postoperative emergent cutting. The plates accept screws with a diameter of 2.3mm and 2.7mm. The Subject Device System consists of self-drilling locking screws and self-tapping locking screws. The selfdrilling locking screws are designed to allow for screw fixation with no pre-drilling. The self-tapping locking screws require pre-drilling before insertion. The Subject Device plates and screws are provided non-sterile and are for single use only. #### V. INDICATIONS FOR USE [§807.92(a)(5 )] #### Subject Device Predicate - K121302 The SternalPlate System is The Biomet Microfixation Sternal indicated for use in stabilization Closure System is indicated for use and fixation of fractures of the in the stabilization and fixation of anterior chest wall including sternal fractures of the anterior chest wall Indications fixation following sternotomy, including sternal fixation following for Use sternal fracture(s), and sternal sternotomy and sternal reconstructive surgical procedures reconstructive surgical procedures, to promote bony fusion. to promote fusion. #### TABLE 1: COMPARISON OF INDICATIONS FOR USE The Indications for Use statement of the Subject Device falls within the scope of the broader Indications statement of the Predicate Device. The differences in the Indications statement for the proposed device in comparison to the predicate does not constitute a new indications for use. {5}------------------------------------------------ #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE [§807.92(a)(6)] The Subject Device is compared to its predicate devices for substantial equivalence based on the following criteria: - A. Principle of Operation - B. Technological and Operational Characteristics # A. Principle of Operation The basic operational principle of the Subject Device, as well as the Predicate Device is for sternal fixation following sternotomy and sternal reconstructive surgical procedures to promote bony fusion. The method of site preparation and fixation is the same for both the Subject and Predicate Device. #### B. Technological and Operational Characteristics At a high level, the Subject Device and Predicate Device are based on the following technological elements: - Material: Both the Subject Device and Predicate Device are made of biocompatible ● titanium according to standards. - Mode of fixation: Implant fixation with screws of the Subject Device is the same as ● the Predicate Device. - Equivalent plate design: The Subject Device has equivalent plate designs compared ● to the Predicate Device consisting of screw holes connected via bars. - Similar Dimension: The Subject Device System contains various plates and screws o of different shapes which are in the same range as the screws and plates of the Predicate Device. Overall these changes do not alter the Subject Device significantly and do not represent a new worst case in design. Traditional 510(k) {6}------------------------------------------------ #### VII. PERFORMANCE DATA [§807.92(b)(1)] The following performance data were provided in support of the substantial equivalence determination. #### Biocompatibility Assessment For assessment of biocompatibility for the Subject Device System, the following documents were used for guidance: · ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. · FDA guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process," issued June 16, 2016. Based on the guidance stated above, the plates and screws of the Subject Device System are categorized as implants, with permanent (>30d) contact in a bone region. The instruments of the Subject Device are categorized as instruments with limited contact (<24h) and instruments without contact. The Subject Device implants are made of titanium according to international standards ASTM F67 / ASTM F136 and have a long history of use in the same indications (ISO 10993-1, Section 4.1). Furthermore, the ASTM standards establish that biological reactivity is acceptable in the clinical conditions of use. During the biocompatibility assessment of the implants, reference devices K151387 (screws) and K014263 (plates) have been identified which are equivalent to the subject device in terms of biocompatibility. Therefore, no further biocompatibility testing was necessary. Traditional 510(k) Stryker SternalPlate System {7}------------------------------------------------ #### Performance Bench Testing The following performance tests were performed in support of the substantial equivalence determination: - Cleaning Validation ● - Sterilization Validation ● - Biocompatibility ● - Product Design Validation ● - MR Compatibility ● - Screw Performance ● - Plate Performance ● 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 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.