SpineJack® Expansion Kit

{0}------------------------------------------------ December 20, 2022 Image /page/0/Picture/1 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. Stryker Instruments Bruce Backlund Principal Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002 Re: K223294 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: October 25, 2022 Received: October 26, 2022 Dear Bruce Backlund: 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. 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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 mediation-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, # Sara S. Thompson -S 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223294 Device Name SpineJack® Expansion Kit ### Indications for Use (Describe) The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures, traumatic vertebral compression fractures according to the AO/Mager! classification) with or without posterior instrumental fixation, and compression from malignant lesions (myeloma or osteolytic metastasis). It is intended to be used in combination with Stryker Vertaplex HV bone cement. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;"> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> | |---------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> | 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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There are no visual elements present. ## Submitter Stryker Instruments 1941 Stryker Way Portage, MI 49002 Contact Bruce Backlund Principal Regulatory Affairs Specialist Ph: 763.762.5902 email: bruce.backlund(@stryker.com Date Prepared: 19 December 2022 #### I. Devices Brand Name: SpineJack® Expansion Kit Common Name: Implantable Fracture Reduction System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: II Product Code: NDN - Cement, Bone, Vertebroplasty #### II. Predicate Devices SpineJack® Expansion Kit, K211238 The predicate has not been subject to a design-related recall, and no reference devices were used in this submission. #### III. Device Description The SpineJack® Expansion Kit ("SpineJack") is an implanted reduction system intended to reduce vertebral compression fractures. The SpineJack is used with a Preparation Kit (sold separately) which prepares the vertebra for implant. The SpineJack is available in three sizes to accommodate different vertebral body sizes, specifically 4.2 mm, 5 mm, and 5.8 mm. After the implant is inserted, it is expanded to reduce the vertebral compression fracture and Vertaplex Radiopaque Bone Cement, or Vertaplex HV Radiopaque Bone Cement (sold separately) is injected at low pressure to fixate the restored vertebral body. #### IV. Proposed Indications for Use, Contraindications Indications for Use: ## SpineJack® Expansion Kit The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. Above the word "stryker" is the text "K223294" and "Page 2 of 6". The text is in a smaller, serif font. The image appears to be a page from a document. vertebral compression fractures, traumatic vertebral compression fractures according to the AO/Magerl classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). It is intended to be used in combination with Stryker Vertaplex and Vertaplex HV bone cement. ## Contraindications: The SpineJack device is not indicated for any application other than that for which the device is designed. The list of contraindications given below is not limited. Refer to the instructions for use of the PMMA cement used in combination with the SpineJack implant. - Patient presenting with non-mobile fractures - Sclerotic fracture or fracture not showing a pseudarthrosis ● - Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement - Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the ● time of surgery or at least 8 days prior to inclusion - Active infection (systemic or in the target vertebra) - Patient suffering from a severe or uncontrolled systemic disease - Patient presenting neurological damage caused by vertebral fracture ● - Patient pregnant or likely to be so or breastfeeding ● - Patient vertebral anatomy not compatible with the size of the implant or instrumentation - Fracture geometry making the insertion of the implant impossible - Patients presenting with type B or C traumatic vertebral fractures according to the Magerl . classification #### V. Comparison with Predicate Device The modification to the SpineJack concern the indications for use and resulting labeling only. No modifications were required of the physical device. Therefore, mechanical design, materials, sizes, packaging, sterilization, user profile, and use environment are identical. | Element of<br>Comparison | SpineJack Expansion Kit<br>(SpineJack)<br>Subject Device | SpineJack Expansion Kit<br>(SpineJack)<br>Predicate Device<br>K211238 | Comparison | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Information Comparison | | | | | Classification | Class II | Class II | Identical | | Regulation | 21 CFR 888.3027 | 21 CFR 888.3027 | Identical | | Product Code | NDN | NDN | Identical | | Panel | Orthopedic | Orthopedic | Identical | | Intended Use and Indications for Use Comparison | | | | | Intended Use | Intended for the reduction of<br>vertebral compression fractures | Intended for the reduction of<br>vertebral compression fractures | Identical | | Indications for Use | The SpineJack Expansion Kit is<br>indicated for use in the reduction<br>of painful osteoporotic<br>vertebral compression fractures,<br>traumatic vertebral compression<br>fractures (Type A fractures<br>according to the AO/Magerl<br>classification) with or without<br>posterior instrumental fixation,<br>and compression fractures that<br>result from malignant lesions<br>(myeloma or osteolytic<br>metastasis). It is intended to be<br>used in combination with Stryker<br>Vertaplex and Vertaplex HV bone<br>cement. | The SpineJack Expansion Kit is<br>indicated for use in the reduction<br>of painful osteoporotic vertebral<br>compression fractures, and<br>traumatic vertebral compression<br>fractures (Type A fractures<br>according to the AO/Magerl<br>classification) with or without<br>posterior instrumental fixation. It<br>is intended to be used in<br>combination with Stryker<br>Vertaplex and Vertaplex HV bone<br>cement. | Different -<br>additional<br>indication for<br>compression<br>fractures that<br>result<br>from malignant<br>lesions<br>(myeloma<br>or osteolytic<br>metastasis) | | Contraindications | Patient presenting with non-mobile fractures Patients presenting with Type B or C traumatic vertebral fractures according to the Magerl Classification. Sclerotic fracture or fracture not showing a pseudarthrosis Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the time of surgery or at least 8 days prior to inclusion Active infection (systemic or in the target vertebra) Patient suffering from a severe or uncontrolled systemic disease Patient presenting neurological damage caused by vertebral fracture Patient pregnant or likely to be so or breastfeeding Patient vertebral anatomy not compatible with the size of the implant or instrumentation Fracture geometry making the insertion of the implant impossible | Patient presenting with non-mobile fractures Patients presenting with Type B or C traumatic vertebral fractures according to the Magerl Classification. Patients presenting with tumoral fractures Sclerotic fracture or fracture not showing a pseudarthrosis Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the time of surgery or at least 8 days prior to inclusion Active infection (systemic or in the target vertebra) Patient suffering from a severe or uncontrolled systemic disease Patient presenting neurological damage caused by vertebral fracture Patient pregnant or likely to be so or breastfeeding Patient vertebral anatomy not compatible with the size of the implant or instrumentation Fracture geometry making the insertion of the implant impossible | Similar-<br>The subject<br>device<br>is proposing the<br>removal of:<br><br>Patients<br>presenting with<br>tumoral<br>fractures as<br>they don't meet<br>the definition of<br>a<br>contraindication<br>and this<br>submission is<br>seeking a<br>cleared<br>indication for<br>tumoral<br>fractures (i.e.<br>fractures caused<br>by malignant<br>lesions such as<br>myeloma or<br>osteolytic<br>metastasis). | | Cement for Use<br>with Implant | | | | | | Intended to be used in<br>combination with Stryker<br>Vertaplex and Vertaplex HV bone<br>cements | Intended to be used in<br>combination with Stryker<br>Vertaplex and Vertaplex HV bone<br>cements | Identical | | Technological Comparison | | | | | Contact | Implantable | Implantable | Identical | | Fundamental<br>Scientific<br>Technology | The Expansion Kit consists of the<br>SpineJack implant and an implant<br>expander. The implant is<br>composed of a deformable<br>element and a locking tube and is<br>made from a titanium alloy. | The Expansion Kit consists of the<br>SpineJack implant and an implant<br>expander. The implant is<br>composed of a deformable<br>element and a locking tube and is<br>made from a titanium alloy. | Identical | | Principal of<br>Operation | The SpineJack is implanted into<br>the vertebra after access is<br>established and the site is<br>prepared for the implant. It is<br>inserted into the vertebra via the<br>pedicle in a collapsed form, and<br>expanded in situ, to achieve<br>reduction of vertebral<br>compression fractures. Once<br>inserted and expanded, PMMA<br>bone cement is injected into the<br>space around the SpineJack to<br>maintain the fracture reduction. | The SpineJack is implanted into<br>the vertebra after access is<br>established and the site is<br>prepared for the implant. It is<br>inserted into the vertebra via the<br>pedicle in a collapsed form, and<br>expanded in situ, to achieve<br>reduction of vertebral<br>compression fractures. Once<br>inserted and expanded, PMMA<br>bone cement is injected into the<br>space around the SpineJack to<br>maintain the fracture reduction. | Identical | | Plate Length (mm) | 14/19/20 | 14/19/20 | Identical | | Total Length (mm) | 20/25/28 | 20/25/28 | Identical | | Height Pre-<br>Expansion (mm) | 4.2/5.0/5.8 | 4.2/5.0/5.8 | Identical | | Maximum Height<br>Post-Expansion<br>(mm) | 12.5/17/20 | 12.5/17/20 | Identical | | Implant Material | Ti-6Al-4V | Ti-6Al-4V | Identical | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Stryker logo in bold, black font. Above the logo, the text "K223294 Page 3 of 6" is visible. The logo is positioned at the top left of the image. The text is likely a document identifier and page number. {6}------------------------------------------------ #### Performance Data VI. No bench or biocompatibility testing was required to support the proposed indications. Additionally, no prospective clinical data was generated for the purpose of supporting this submission. The proposed indications are supported by clinical data collected from Literature and Real-World Evidence (RWE). Literature summary: Relevant publications were thoroughly analyzed to determine the safety and effectiveness of the SpineJack system for use for treatment of malignant, spinal bone tumors. The literature shows that the safety profile for SpineJack/cement for use in painful osteoporotic VCFs, traumatic VCFs and malignant lesions (myeloma or osteolytic metastasis) VCFs is nearly the same. No different types of adverse events are seen in malignant lesions (myeloma or osteolytic metastasis) as compared to trauma or osteoporosis, and those adverse events that they have in common (cement leakage) occur at similar rates. All potential risks were noted and evaluated specifically with regard to an acceptable benefit/risk ratio. Across all studies there was statistically significant pain improvement with sustained long-term relief as measured by the Visual Analogue Scale (VAS). This decrease in pain occurred regardless of the treatment details or concomitant procedures performed and was found to persist for up to 5 years after the initial Kor {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Stryker logo in bold, black font. Above the logo, on the right side, is the text "K223294" followed by "Page 5 of 6" on the line below. The logo is large and dominates the left side of the image, while the additional text is smaller and positioned in the upper right corner. treatment. It was found in these studies that the SpineJack system can not only reduce pain but also improve the quality of life for this patient cohort demonstrated by the EO5 VAS and Oswestry Disability Index. The data demonstrated that the SpineJack system is an effective treatment option, notably for pain relief, in treating malignant spinal tumors. Patient Demographics: The studies provided evidence on 304 patients who received SpineJack System, of which 117 were treated for malignant vertebral fractures. These studies took place in Spain, France, Switzerland and in the United States. The age range of patients was between 23 to 90 years of age with the mean age in all studies recorded above 62 years. Of the 304 patients 136 were male (45%) and 166 (55%) were female. Body mass index was recorded in two studies as 26.0 ± 4.6 kg/m2 and 28.8 ± 5.8kg/m2. The one study in the United States reported on ethnicity with 70% of the study being Caucasian, and the ethnicity of the remaining 30% was not documented. EU regulations do not permit collection of race or ethnicity data however, no race or ethnic group were excluded based on exclusion criteria in any study. Fractures were located from T6 to L4, with the thoracolumbar junction the most affected area. The patients had a wide range of primary tumor locations including but not limited to breast, lung, ovarian, kidney, melanoma and gastrointestinal. #### VII. Conclusion The evidence provided within this submission supports that the proposed indications are a subset of the intended use of the predicate (reduction/fixation of vertebral compression fractures), just as the predicate indications painful osteoporotic vertebral compression fractures, and traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation are a subset of the intended use. Therefore, the subject device has the same intended use as the predicate. The characteristics described above in the Performance Data section are consistent with the US malignant, spinal bone tumor population. The average age of patients affected by secondary spinal tumors is 55 - 60 years 1. Furthermore, many of the primary tumors mentioned above affect persons of increased age, with 60% of cancer patients over 65 years of age2 which is in line with the population captured here. Additionally, the information from these studies does include information on a patient cohort from the United States. This study included 30 patients (n=19 for tumor indication) of which 12 patients were male and 18 were female, with a mean age of 62.7 (±12.8) and fractures located from 77 to L4, with most fractures occurring at T12 and L1. United States census population estimates in July 2021 reported that more than 70% of Americans are in the ethnic group of "White alone"3. In the 2010 census more than 70% of Americans were in the ethnic group of "White/ Caucasian Americans"4. According to U.S. Office of Management and Budgets, "White" refers to a person having origins in any of the original peoples of Europe, the Middle East, or North Africa4. The EU Statistics on migration to Europe (2022) reports that 5.3% of all residents come from outside the European Union (EU) and 8.4% of residents were born outside of the EU5, further demonstrating that the current EU {8}------------------------------------------------ population is not homogeneous. Therefore, any clinical data stemming from the European population are fully transferrable to the American population. The RWE provided demonstrates that there are not different types of questions related to safety or effectiveness when SpineJack/cement are used for reduction/fixation of malignant lesions (myeloma or osteolytic metastasis) VCFs. The literature shows that the safety profile for SpineJack/cement for use in painful osteoporotic VCFs, traumatic VCFs and malignant lesions (myeloma or osteolytic metastasis) VCFs is nearly the same. No different types of adverse events are seen in malignant lesions (myeloma or osteolytic metastasis) as compared to trauma or osteoporosis, and those adverse events that they have in common (cement leakage) occur at similar rates. The subject devices are safe and effective for their intended use and indications for use. The intended use is the same as the predicate, and the difference in indication does not pose different questions of safety or effectiveness. The proposed devices are at least as safe and effective as the predicate devices for the proposed indications. The technological characteristics are identical between subject and predicate, as no physical design changes were required to allow for use in malignant lesions (myeloma or osteolytic metastasis) vertebral compression fractures. Therefore, a decision of substantial equivalence is supported. References: - Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-1. Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7. PMID: 10735013 - SEER Cancer Statistics Review 1975-2000, National Cancer Institute. Retrieved from 2. https://seer.cancer.gov/archive/csr/1975-2000/ - 3. Retrieved from https://www.census.gov/quickfacts/fact/table/US/PST045221. Accessed on December 13th, 2022. - Retrieved from 4. https://www.census.gov/content/dam/Census/library/publications/2011/dec/c2010br-05.pdf Accessed on December 14th, 2022 - Retrieved from https://commission.europa.eu/strategy-and-policy/priorities-2019-5. 2024/promoting-our-european-wav-life/statistics-migration-europe en Accessed on December 14th, 2022