SpineJack Expansion Kit

{0}------------------------------------------------ October 20, 2020 Image /page/0/Picture/1 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 this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. Stryker Corporation Kristi Ashton Senior Staff RA Specialist 1926 Stryker Way Kalamazoo, Michigan 49002 Re: K202393 Trade/Device Name: SpineJack® Expansion Kit Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN Dated: August 18, 2020 Received: August 21, 2020 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). 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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, for Laura C. Rose, Ph.D. 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) K202393 Device Name SpineJack® Expansion Kit (Spinejack ®) Indications for Use (Describe) The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex® HV bone cement. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------| | <div> <span style="text-decoration: overline;">×</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </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. 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The background is plain white. ## 510(K) SUMMARY | 510(K) SUMMARY: SPINEJACK® EXPANSION KIT | | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Stryker Instruments<br>1941 Stryker Way<br>Kalamazoo, MI 49002 USA<br>Contact Name: Kristi Ashton<br>Title: Senior Staff RA Specialist<br>Phone: 269-800-1692<br>E-mail: Kristi.Ashton@Stryker.com | | Date prepared: | October 20, 2020 | | Subject Device Trade Name: | SpineJack Expansion Kit (SpineJack) | | Common Name: | Implantable Fracture Reduction System | | Classification Name: | Cement, Bone, Vertebroplasty | | Product Code: | NDN | | Regulatory Class: | II | | Regulation Name: | Polymethylmethacrylate (PMMA) | | Regulation Number: | 21 CFR 888.3027 | | Predicate Device: | SpineJack Expansion Kit (SpineJack), K181262 | | Device Description: | The SpineJack Expansion Kit (herein referred to as “SpineJack”) is an<br>implanted fracture reduction system, intended to reduce vertebral<br>compression fractures. The SpineJack Expansion Kit is used with the<br>Preparation Kit. The Expansion Kit is available in three sizes, to<br>accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and<br>Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and a<br>validated Stryker PMMA bone cement, such as Stryker VertaPlex® or<br>VertaPlex® HV Bone Cement, is injected at a low pressure to stabilize<br>the restored vertebral body. The bone cement and its delivery system are<br>intended to be used with the SpineJack but are sold separately. | | Indications for Use | The SpineJack® Expansion Kit is indicated for use in the reduction of<br>painful osteoporotic vertebral compression fractures. It is intended to be<br>used in combination with Stryker Vertaplex® and Vertaplex® HV Bone<br>Cement. | | Non-Clinical Testing | Non-clinical testing was deemed not required for this 510(k). The<br>SpineJack implant was previously tested to be non-pyrogenic. | | Clinical Testing | Clinical testing was deemed not required for this 510(k) | | Other Evidence: | Clinical literature, post-market surveillance data and a risk analysis per<br>ISO 14971 were used in support of the subject modification. | | Summary of Technological Characteristics | | Table 1 below details the comparisons between the subject and predicate devices. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the word "stryker" in a bold, sans-serif font. Above the word "stryker" is the text "K202393" in a smaller font size. The word "stryker" is the main focal point of the image. | Table 1 Comparison of Regulatory and Technical Characteristics | | | | | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Element of<br>Comparison | SpineJack<br>Subject Device | SpineJack<br>Predicate Device | Comparison | | | Indications for Use | The SpineJack®<br>Expansion Kit is<br>indicated for use in the<br>reduction of painful<br>osteoporotic vertebral<br>compression fractures. It<br>is intended to be used in<br>combination with<br>Stryker Vertaplex® and<br>Vertaplex® HV bone<br>cements. | The SpineJack®<br>Expansion Kit is<br>indicated for use in the<br>reduction of painful<br>osteoporotic vertebral<br>compression fractures.<br>It is intended to be used<br>in combination with<br>Stryker Vertaplex® and<br>Vertaplex ® HV bone<br>cements. | Identical | | | Contraindications | Patients presenting with<br>type B or C traumatic<br>vertebral fractures<br>according to the Magerl<br>classification. | Patient presenting with<br>traumatic fractures<br>(Reference IFU for full<br>list of contraindications) | Different-It is proposed<br>that Type A trauma<br>fractures are removed<br>from the list of<br>contraindications for<br>SpineJack. Clinical<br>literature, post-market data<br>and a risk assessment per<br>ISO 14971 were provided<br>to support the safety of<br>this modification. This<br>change does not raise new<br>types of safety and<br>effectiveness questions<br>regarding the use of the<br>subject device. | | | Contact | Implantable | Implantable | Identical | | | Material | Ti-6Al-4V with PMMA<br>(cement injected) | Ti-6Al-4V with PMMA<br>(cement injected) | Identical | | | Length (mm) | 14 - 20 (plate length) | 14 - 20 (plate length) | Identical | | | Width (mm) | 4 - 6 | 4 - 6 | Identical | | | Height pre and post<br>expansion (mm) | 4 - 20 (Surgeon<br>determined) | 4 - 20 (Surgeon<br>determined) | Identical | | | Expansion Mechanism | Plastic deformation of<br>struts, continuous | Plastic deformation of<br>struts, continuous | Identical | | | Number of Implants<br>Typically Used | 1-2 per patient | 1-2 per patient | Identical | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. Above the word "stryker" is the alphanumeric code "K202393". The text is black and the background is white. The image appears to be a logo or product identifier. SpineJack has the same intended use, fundamental scientific technology, principle of operation, and mode of action as the predicate device. An evaluation of clinical literature, post-market data in US and Europe and risk per ISO 14971 provide the evidence to support the removal of Type A trauma fractures from the contraindications. The use of post-market data from Europe demonstrates the history of safe and effective use of the Conclusion product in Type A traumatic fractures since 2008. The evaluation of the post-market data, use history and a clinical literature review provide established evidence which confirm that the subject modification does not raise new types of safety and effectiveness questions regarding the use of the subject device. Therefore, it is proposed that the subject SpineJack is equivalent to the predicate device.