Stryker Universal Mesh

{0}------------------------------------------------ November 8, 2017 Stryker Gregory Gohl Sr. Regulatory Affairs Specialist 750 Trade Centre Wav - Suite 200 Portage, Michigan 49002 Re: K170773 Trade/Device Name: Stryker Universal Mesh Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: October 11, 2017 Received: October 12, 2017 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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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. 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/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, Mary S. Runner -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K170773 Device Name Universal Mesh Indications for Use (Describe) The Universal Mesh is indicated for non-load-bearing reconstruction in the maxillofacial skeleton of patients in whom skeletal growth is complete. 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) 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}------------------------------------------------ SECTION 5 510(k) Summary {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and the letters are closely spaced together. There is a registered trademark symbol to the upper right of the word. The word is in black and the background is white. # Section 5. 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. KG<br>Boetzinger Strasse 41<br>79111 Freiburg, Germany | |-------------------------------|-------------------------------------------------------------------------------------| | Submitter/ Contact<br>Person: | Gregory Gohl<br>Sr. Regulatory Affairs Specialist | Stryker Craniomaxillofacial 750 Trade Centre Way Portage, MI 49002 Phone: 269-389-4319 Fax: 877-648-7114 Date prepared: October 11, 2017 - DEVICE [§807.92(a)(2)] II. | Trade Name: | Universal Mesh | |-------------|----------------| | | | Common or Usual Plate. Bone name: Bone Plate; 21 CFR 872.4760 Classification name: Regulatory Class: Class II Product Code: JEY #### PRIMARY PREDICATE DEVICE [§807.92(a)(3)] III. Universal CMF System - K022185 - A. REFERENCE DEVICE Universal Mesh - Cranial (K161821) This submission is one of two submissions to the FDA for the subject Universal Mesh implants. The Universal Mesh with a dental indication (herein referred to as {5}------------------------------------------------ Universal Mesh - Dental) submission was originally submitted to the Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID), Dental Devices Branch (DEDB) in 2016. During substantive review of that submission and a hold Request for Additional information including a teleconference with the FDA on April 27, 2016, the FDA determined only the maxillofacial portion of the proposed craniomaxillofacial Indication for Use could be reviewed by DEDB. and that the cranial portion of the Indication for Use required a duplicate submission to the Division of Neurological and Physical Medicine Devices (DNPMD), Neurodiagnostic and Neurosurgical Devices Branch (NNDB). The resulting Universal Mesh with a cranial indication (K161821) has since been cleared, and for ease of review will be referenced as Universal Mesh - Cranial. During an April 27, 2016 teleconference with the FDA, it was discussed with Stryker that the use of the Universal CMF System (K022185) as the Primary Predicate Device in both submissions was possible based on the technological characteristics, overall intended use, and the history of the application. Each of these facts necessitated the present Universal Mesh - Dental submission. #### DEVICE DESCRIPTION [§807.92(a)(4)] IV. The Universal Mesh, which is the brand name of the subject device, consists of mesh implants in different sizes (40x40mm, 90x90mm, 120x120mm, 200x200mm), thicknesses (0.3mm, 0.6mm and 0.8mm), and perforation patterns, which include the 1.2mm and 1.5/ 1.7mm Dynamic Mesh pattern and Hybrid Mesh pattern. The meshes can be modified with trimming and bending instruments for an anatomical fit and are malleable for threedimensional adaptations. The mesh can be fixated to the bone with screws from the previously marketed Stryker CMF implant systems. In addition, the necessary instrumentation for mesh modification and storage is included with the system. The implants of the Universal Mesh are provided non-sterile and are for single use only. The instrumentation and storage system is reusable. {6}------------------------------------------------ #### V. INDICATIONS FOR USE [§807.92(a)(5 )] | TABLE 1: COMPARISON OF INDICATIONS FOR USE | | | | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | Subject Device | Primary Predicate Device—<br>K022185 | | | Indications for<br>Use | The Universal Mesh is indicated<br>for non-load-bearing<br>reconstruction in the maxillofacial<br>skeleton of patients in whom<br>skeletal growth is complete. | The Stryker Leibinger Universal<br>CMF System is a Cranio-<br>maxillofacial (CMF) plate and<br>screw system intended for<br>osteotomy, stabilization and rigid<br>fixation of CMF fractures and<br>reconstruction. | | | | Subject Device | Primary Predicate Device-<br>K022185 | | | Principle of<br>Operation | the reconstruction of the bony<br>areas of the maxillofacial skeleton | the reconstruction of the bony areas<br>of the maxillofacial skeleton | | | Technological<br>and<br>Operational<br>Characteristics | | | | | - Materials | titanium according to ASTM F67 | titanium according to ASTM F67 | | | - Mode of<br>Fixation | implant fixation with screws | implant fixation with screws | | | - Mesh Pattern | screw holes connected via bars;<br>for the Dynamic Mesh pattern<br>countersinks were added to the<br>screw holes; | screw holes connected via bars | | | - Mesh<br>Design/Sizes | Size: 40x40mm, 90x90mm,<br>120x120mm, 200x200mm<br>Thicknesses: 0.3mm, 0.6mm,<br>0.8mm | Size: 40x40mm, 90x90mm,<br>120x120mm, 200x200mm<br>Thicknesses: 0.3mm, 0.6mm | | ## TABLE 1: COMPARISON OF INDICATIONS FOR USE The Primary 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 Universal Mesh falls within the scope of the broader Indications statement of the Primary Predicate Device. The differences in the Indications statement for the proposed device in comparison to the Primary Predicate Device does not constitute a new intended use. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PRIMARY PREDICATE DEVICE [§807.92(a)(6)] The Universal Mesh is compared to its Primary Predicate Device for substantial equivalence based on the following criteria: - A. Principle of Operation - B. Technological and Operational Characteristics {7}------------------------------------------------ Image /page/7/Picture/3 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. A small circle with an "R" inside is located to the upper right of the word. The background is plain white. For both, Principle of Operation and Technological and Operational Characteristics, the Subject device and the Primary Predicate Device are equivalent. Deviations in regard to pattern shapes or mesh thickness do not alter the Subject device significantly, and it does not represent a new worst case in design. {8}------------------------------------------------ ### 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 Universal Mesh was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1 Evaluation and testing within a risk management process", issued June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the 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 Primary Predicate Device. Cytotoxicity testing was performed using DIN EN 10993-5:2009. Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. Chemical characterization was performed using ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical Characterization of materials. The tests supported the biocompatibility of the device. {9}------------------------------------------------ ## Performance Bench Testing | Test | Test Method Summary | Results | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | Life time<br>reprocessing | Verify the reprocessing life of the Subject device, instruments, and<br>storage container are according to internal standard. | Internal acceptance<br>criterion were met; tests<br>were passed. | | Cleaning<br>Validation | Verify the cleaning process for Subject device, instruments and<br>storage container are according to recommendations in ISO 17664,<br>AAMI TIR 30, and AAMI TIR 12. | Method validated. | | Sterilization<br>Validation | Validate the sterilization instructions for the Subject device,<br>instruments, and storage container are according to internal standard.<br>Referenced standards: ISO 14937, ISO 17664, ISO 17665 - 1&2,<br>AAMI TIR 12, AAMI ST 81, AAMI ST79. | Method validated. | | Mechanical<br>performance<br>Testing | 4 point-bending Static Load Test and Dynamic Load Test according<br>to ASTM F382 against Primary Predicate Device. | Acceptance criterion<br>were met; tests were<br>passed. | | Corrosion<br>Testing | Verify corrosion behavior of Subject device, instruments, and storage<br>device. | Acceptance criterion<br>were met; test was<br>passed. | | MR<br>Compatibility | Magnetic Resonance (MR) testing was performed on the subject<br>device mesh implants in accordance with FDA guidance for industry<br>"Assessment of Radiofrequency - Induced Heating in the Magnetic<br>Resonance (MR) Environment for Multi-Configuration Passive<br>Medical Devices," March 22, 2016. MR heat testing has been<br>performed on the Subject device according to FDA final guidance<br>"Establishing Safety and Compatibility of Passive Implants in the<br>Magnetic Resonance (MR) Environment," December 11, 2014. | Based on the results of<br>these evaluations, the<br>implants of the<br>Universal Mesh will be<br>labeled as MR<br>Conditional. | The following performance bench tests were completed. 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 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.