Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System

{0}------------------------------------------------ Build Correspondence Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. March 31, 2020 Stryker Corporation Kristi Ashton Sr Staff Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001 #### Re: K192818 Trade/Device Name: Vertaplex HV High Viscosity Radiopaque Bone Cement, ES2® Augmentable Spinal System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: PML, NKB, NDN Dated: September 30, 2019 Received: October 1, 2019 ## Dear Kristi Ashton: 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 {1}------------------------------------------------ 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, Jesse Muir, PhD Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192818 Device Name Vertaplex® HV High Viscosity Radiopaque Bone Cement #### Indications for Use (Describe) VertaPlex® HV High Viscosity Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacroplasty or sacroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with ES2® Augmentable Spinal System, Vertaplex® HV High Viscosity Radiopaque Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Vertaplex® HV High Viscosity Radiopaque Bone Cement and the ES2® Augmentable Spinal System are for use together at spinal levels where the structural integrity of the spine is not severely compromised. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192818 Device Name ES2 ® Augmentable Spinal System #### Indications for Use (Describe) When used without cement, the ES2® Augmentable Spinal System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), pseudarthrosis, and/or failed previous fusion. When used in conjunction with the Vertaplex® HV High Viscosity Radiopaque Bone Cement, the ES2® Augmentable Spinal System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. ES2® Augmentable Spinal System augmented with the Vertaplex® HV High Viscosity Radiopaque Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised. Type of Use (Select one or both, as applicable) | <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|----------------------------------------------| | <span></span> | 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." {4}------------------------------------------------ 510(k) Number: K192818 Date Submitted: March 26, 2020 Traditional 510(k) Stryker Instruments 4100 East Milham Ave, Kalamazoo, MI 49001 USA Image /page/4/Picture/3 description: The image shows the text 'K192818' on the first line, followed by 'Page 1 of 5' on the second line. The text is in a simple, sans-serif font and is positioned at the top of the image. The layout suggests this is a header or identifying information for a document or a multi-page set of materials. The page number indicates that there are a total of five pages in the document. stryker® Instruments # 510k Summary ## 1. Submitter Stryker Instruments 4100 East Milham Avenue Kalamazoo, MI 49001 Phone +1 (269) 323-7700 Fax +1 (269) 324-5412 ## FDA Establishment Registration Number: 1811755 ## Contact: Kristi Ashton Stryker Instruments Regulatory Affairs Sr. Staff Regulatory Affairs Specialist Phone: +1 (269) 800-1692 Kristi.Ashton@Stryker.com Date Submitted: March 26, 2020 ## 2. Subject Devices Trade Name: Vertaplex ® HV High Viscosity Radiopaque Bone Cement Common Name: Polymethylmethacrylate (PMMA) Bone Cement Product Codes: PML, NDN Regulation: 21CFR888.3027 Trade Name: ES2® Augmentable Spinal System Common Name: Thoracolumbosacral pedicle screw system Product Codes: NKB Regulation: 21CFR888.3070 | Predicate Device (Cement) | | | | |------------------------------------------------------|---------|--------------------|---------------| | Kyphon Xpede Bone<br>Cement/Medtronic HV Bone Cement | K171938 | NDN, PML | 21CFR888.3027 | | Predicate Device (Screw Systems) | | | | | CD Horizon Fenestrated Screw Set<br>(Primary) | K171938 | MNI | 21CFR888.3070 | | ES2® Spinal System (Secondary) | K122845 | NKB, KWP, MNH, MNI | 21CFR888.3070 | ## 3. Legally Marketed Predicate Device(s) {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a document page with the text "K192818" and "Page 2 of 5" at the top. Below that is the Stryker logo in bold black letters. Underneath the logo is a horizontal line, and below that is the word "Instruments" in bold black letters. The page appears to be part of a larger document, possibly a manual or catalog. Stryker Instruments 4100 East Milham Ave, Kalamazoo, MI 49001 USA # 4. Device Description VertaPlex® HV High Viscosity Radiopaque Bone Cement is bone cement comprised of a liquid component and powder component which when mixed together polymerize to form a hardened acrylic polymer. The mixture is in an injectable state for a period of time before it cures to form a hardened structure, capable of long-term load support and bone augmentation in the treatment of symptomatic osteoporotic vertebral compression fractures. The powder component of VertaPlex® HV High Viscosity Radiopaque Bone Cement is Ethylene Oxide (EO) sterilized and is packaged in a polyethylene/foil pouch while the liquid monomer is aseptically filled into an amber glass ampoule which is EO sterilized. The device contains the following components: Polymer powder, Monomer liquid and Barium Sulfate. Accessories to the subject cement device are compatible Stryker cement mixers such the Stryker Autoplex System and the Stryker PCD System. ES2® Augmentable Spinal System is a gamma sterilized, titanium implantable screw with fenestrations and blocker designed as a stabilization solution for the aging spine. The subject system (screw and blocker) has been developed to provide improved anchorage of pedicle screws with and without Vertaplex® HV High Viscosity Radiopaque Bone Cement during pedicle screw augmentation in vertebrae with reduced bone quality as compared to pedicle screw augmentation in healthy bone. # 5. Intended Use/Indications for use ## VertaPlex® HV High Viscosity Radiopaque Bone Cement: VertaPlex® HV High Viscosity Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with ES2® Augmentable Spinal System, VertaPlex® HV High Viscosity Radiopaque Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. VertaPlex® HV High Viscosity Radiopaque Bone Cement and the ES2® Augmentable Spinal System are for use together at spinal levels where the structural integrity of the spine is not severely compromised. # ES2® Augmentable Spinal System: When used without cement, the ES2® Augmentable Spinal System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the text "K192818 Page 3 of 5" at the top, followed by the Stryker logo. The Stryker logo is in black and features the company's name in a bold, sans-serif font. The logo also includes the registered trademark symbol. Instruments the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion. When used in conjunction with the VertaPlex® HV High Viscosity Radiopaque Bone Cement, the ES2® Augmentable Spinal System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. ES2® Augmentable Spinal System augmented with the Vertaplex® HV Radiopaque Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised. #### 6. Comparison of Technological Characteristics with the Predicate Device The Stryker Vertaplex® HV High Viscosity Radiopaque Bone Cement has not changed since it was cleared via K150582 and has the same intended use, principle of operation, and mode of action as the predicate devices. In addition, Vertaplex® HV High Viscosity Radiopaque Bone Cement and Kyphon Xpede Bone cement were previously determined to be substantially equivalent per K163032. The Stryker ES2® Augmentable Spinal System has the same intended use as the predicate devices. The majority of the technical characteristics are similar/identical to the predicate devices K171938 CD Horizon Fenestrated Screw System and the secondary predicate K122845 ES2®Spinal System with a few exceptions such as added fenestrations and overall sterility. These differences have been found through testing, clinical literature, and a risk analysis to be insignificant and do not raise new questions of safety and effectiveness. ## 7. Non-Clinical ## Bench Static testing and interconnection strength testing were completed according to ASTM F1798-12 and Static pullout was performed per ASTM F1717-12. In addition, cadaver validation was performed. The subject devices were tested and met all respective acceptance criteria as specified per the individual test report. The testing was conducted in as similar a manner as possible to the clinical setting using the final finished form of the device. The acceptance criteria for the subject device were similar to the acceptance criteria for the Stryker predicate device. The performance testing further demonstrates equivalence because the subject device is shown to have equivalent functional characteristics as the predicate device. ## Sterilization and Shelf Life Vertaplex® HV Radiopaque Bone Cement will be sterilized per the same ETO methodology and dosage as was listed in submission K091606. The shelf life of 36 months for the subject cement has not been modified since submission K150582. The Vertaplex® HV Radiopaque Bone cement has been tested for bacterial endotoxins using {7}------------------------------------------------ Image /page/7/Picture/10 description: The image shows the Stryker logo with the word "Instruments" written below it. Above the logo, the text "K192818" and "Page 4 of 5" are printed. The Stryker logo is in bold, black font, and the word "Instruments" is in a smaller, bold, black font. Stryker Instruments 4100 East Milham Ave, Kalamazoo, MI 49001 USA Limulus amebocyte lysate (LAL) reagent and kinetic-turbidimetric methodology per ANSI/AAMI ST72:2011(R2016). The endotoxin limits for the Vertaplex® HV Radiopaque Bone Cement are <2.15 EU/device, as recommended for devices that have the potential to unintentionally extravasate out of the vertebral body, contact the cerebrospinal fluid or the circulatory system, resulting in exposure. The ES2® Augmentable Spinal System is sterilized by gamma irradiation in accordance with AAMI guidelines and ISO 11137-2:2013 "Sterilization of health care products -Radiation - Part 2 to achieve sterility assurance level of 10-6. Additionally, the ES2® Augmentable Spinal System has been tested for bacterial endotoxins using Limulus amebocyte lysate (LAL) reagent and kinetic-turbidimetric methodology per ANSVAAMI ST72:2011(R2016). The endotoxin limits for the ES2® Augmentable Spinal System are <20 EU/device, as recommended for devices that are not intended to contact the cerebrospinal fluid. ES2® Augmentable Spinal System has a shelf life of 5 years based on aging studies leveraged from the Stryker Spine Thoracolumbar (TL) Portfolio. This testing was completed for all packaging assemblies of TL System (Real Time and Accelerated Aging) in accordance with ASTM F1980 and ISO 11607. ## Biocompatibility The materials, processes and sterilization methodology for Vertaplex® HV Radiopaque Bone Cement are identical to that which was cleared in the original Vertaplex® HV submission K091606. Vertaplex® HV Radiopaque Bone Cement remains a biocompatible device. The grade of material used by Stryker to manufacture the ES2® Augmentable Spinal System are ASTM F136 and ISO 5832 recommended. Since, the material has repetitively undergone traditional manufacturing processes and are documented as having a long history of use substantiated with supporting data from testing and literature citations, it was deemed unnecessary to conduct additional testing as allowed per FDA Guidance on ISO 10993. A biological risk assessment was completed and supported by information on the ES2® Augmentable Spinal System materials of construction, manufacturing processes/aids, gathered toxicological data on these materials, biological/chemical evaluation of equivalent devices, as well as other available literature. Based upon examination of this information, the risk assessment indicates that the risk of a toxic effect from the ES2® Augmentable Spinal System is negligible and that the devices can be considered safe for use as intended. {8}------------------------------------------------ Stryker Instruments 4100 East Milham Ave, Kalamazoo, MI 49001 USA Image /page/8/Picture/2 description: The image shows a logo and some text. The text at the top reads "K192818 Page 5 of 5". Below that is the Stryker logo. The word "Instruments" is at the bottom of the image. #### 8. Clinical No clinical testing was deemed necessary for this 510(k). A clinical literature review has been completed to support this pre-market notification. The clinical literature review provides evidence to support the safety and effectiveness of the use of PMMA bone cement with augmentable pedicle screws systems. #### 9. Substantial Equivalence Conclusion Based upon the non-clinical testing completed and additional supporting documentation provided in this pre-market submission, the subject cement device and screw system have demonstrated safety and effectiveness. Based on the information provided, it can be concluded that the subject cement device. Vertaplex® HV High Viscosity Radiopaque Bone Cement, is substantially equivalent to the predicate cement devices, K171938 Kyphon Xpede Bone Cement/Medtronic HV Bone Cement; and the subject screw system, ES2® Augmentable Spinal System, is substantially equivalent to the predicate screw systems, K171938 CD Horizon Fenestrated Screw System and K122845 ES2® Spinal System.