SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement

K211238 · Stryker Instruments · NDN · Jun 25, 2021 · Orthopedic

Device Facts

Record IDK211238
Device NameSpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
ApplicantStryker Instruments
Product CodeNDN · Orthopedic
Decision DateJun 25, 2021
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3027
Device ClassClass 2
AttributesTherapeutic

Intended Use

The SpineJack® Expansion Kit is indicated for use in the reduction of 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. They are intended to be used in combination with Stryker Vertaplex® and Vertaplex® HV bone cement. Vertaplex® Radiopaque Bone Cement is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with the Spinelack Expansion Kit, Vertaplex® Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures. Vertaplex® HV 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. 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® High Viscosity (HV) 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® High Viscosity (HV) 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. When used in conjunction with the Spinelack Expansion Kit, Vertaplex® High Viscosity (HV) Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures.

Device Story

SpineJack Expansion Kit: implantable titanium alloy reduction system; inserted via pedicle in collapsed form; expanded in situ to reduce vertebral compression fractures; stabilized via injection of Vertaplex or Vertaplex HV PMMA bone cement. Vertaplex/Vertaplex HV: PMMA bone cements; powder/liquid components mixed to form hardened acrylic polymer; provides load support and bone augmentation. Used in OR by physicians for vertebroplasty/kyphoplasty. Output: restored vertebral body height and fracture fixation. Benefits: pain relief, spinal column integrity restoration, fracture reduction. No physical device modifications; labeling update only.

Clinical Evidence

No new bench, biocompatibility, or prospective clinical testing performed. Evidence consists of Real World Evidence (RWE) from published clinical literature and an outside-of-US post-market clinical study. Data indicates safety profile for traumatic vertebral compression fractures is comparable to osteoporotic fractures, with similar rates of common adverse events like cement leakage.

Technological Characteristics

Implant: Ti-6Al-4V titanium alloy; 4.2/5.0/5.8 mm heights. Cement: Polymethylmethacrylate (PMMA) bone cement; powder/liquid polymerization. Principle: Mechanical expansion followed by chemical cement fixation. No software or energy source.

Indications for Use

Indicated for patients with painful osteoporotic or traumatic (AO/Magerl Type A) vertebral compression fractures, pathological vertebral fractures (osteoporosis, benign/malignant lesions), and sacral fractures. Contraindications include non-mobile fractures, Type B/C traumatic fractures, tumoral fractures, sclerotic fractures, titanium/PMMA allergy, irreversible coagulopathy, active infection, severe systemic disease, neurological damage, pregnancy, or incompatible anatomy.

Regulatory Classification

Identification

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ June 25, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. Stryker Instruments Susanne Galin Senior Principal Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002 # Re: K211238 Trade/Device Name: SpineJack® Expansion Kit, Vertaplex® Radiopaque Bone Cement, Vertaplex® High Viscosity (HV) Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN, LOD, PML Dated: April 24, 2021 Received: April 26, 2021 Dear Susanne Galin: 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 {1}------------------------------------------------ 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) 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 (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 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, 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) K211238 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, and traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation. They are intended to be used in combination with Stryker Vertaplex® and Vertaplex® HV bone cement. | 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." {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211238 Device Name Vertaplex® Radiopaque Bone Cement ### Indications for Use (Describe) Vertaplex® Radiopaque Bone Cement is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with the Spinelack Expansion Kit, Vertaplex® Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------------| | ☑ 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." {4}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211238 Device Name Vertaplex® HV Radiopaque Bone Cement ### Indications for Use (Describe) Vertaplex® HV 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. 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® High Viscosity (HV) 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® High Viscosity (HV) 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. When used in conjunction with the Spinelack Expansion Kit, Vertaplex® High Viscosity (HV) Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> 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. 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." {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 "K211238". The text is black and the background is white. ### Submitter Stryker Instruments 1941 Stryker Way Portage, MI 49002 ## Contact Susanne Galin, RAC Senior Principal Regulatory Affairs Specialist Ph: 812.345.7917 email: susanne.galin(@stryker.com Date Prepared: 24 April 2021 #### 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 Brand Name: Vertaplex® Radiopaque Bone Cement Common Name: PMMA Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: II Product Code: NDN, Cement, Bone, Vertebroplasty LOD, Bone Cement Brand Name: Vertaplex® High Viscosity (HV) Radiopaque Bone Cement Common Name: PMMA Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: II Product Code: NDN, Cement, Bone, Vertebroplasty PML, Bone Cement, Posterior Screw Augmentation {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. Above the word "stryker" is the alphanumeric code "K211238". The word "stryker" is the most prominent feature of the image, with the code being smaller and less noticeable. #### II. Predicate Devices SpineJack® Expansion Kit, K202393 Vertaplex Radiopaque Bone Cement, K072118 Vertaplex High Viscosity (HV) Radiopaque Bone Cement, K192818 These predicates have 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 Vertablex HV Radiopaque Bone Cement (sold separately) is injected at low pressure to fixate the restored vertebral body. #### IV. Proposed Indications for Use, Contraindications ## SpineJack Expansion Kit Indications for Use: The SpineJack® Expansion Kit is indicated for use in the reduction of 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. They are intended to be used in combination with Stryker Vertaplex® HV Radiopaque bone cements. 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 ● - . 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 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is in all lowercase letters and is black. Above the word "stryker" is the alphanumeric code "K211238". - 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 ## Vertaplex Radiopaque Bone Cement # Indications for Use: Vertaplex® Radiopaque Bone Cement is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with SpineJack Expansion Kit, Vertaplex® Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures. Contraindications: - Allergies or sensitivity to any of its chemical components ● - . The presence of active or incompletely treated infection at the site where the bone cement is to be applied - Coagulation disorders, or with severe cardiopulmonary disease ● - . Spinal stenosis (>20% by retropulsed fragments) - Vertebral plana (collapse >90%) ● - Compromise of the vertebral body or the walls of the pedicles - For vertebroplasty, unstable vertebral fractures due to posterior involvement ● - Patient clearly improving on medical therapy ● - Prophylaxis in metastatic or osteoporotic patients with no evidence of acute fracture ● - For vertebroplasty, non-pathological acute traumatic fractures of the vertebra # Vertaplex HV High Viscosity Radiopaque Bone Cement # Indications for Use: Vertaplex® HV 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. Vertablex® High Viscosity (HV) 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 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. Above the word "stryker" is the alphanumeric code "K211238". The word "stryker" is in all lowercase letters and is in black. The alphanumeric code is in a smaller font size and is also in black. the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Vertaplex® High Viscosity (HV) 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. When used in conjunction with SpineJack Expansion Kit, Vertaplex® High Viscosity (HV) Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures. Contraindications: - Allergies or sensitivity to any of its chemical components ● - The presence of active or incompletely treated infection at the site where the bone cement is to be injected. - Coagulation disorders, or with severe cardiopulmonary disease ● - Spinal stenosis (>20% by retropulsed fragments) ● - Vertebral plana (collapse >90%) ● - Compromise of the vertebral body or the walls of the pedicles - For vertebroplasty, unstable vertebral fractures due to posterior involvement ● - Patient clearly improving on medical therapy - Prophylaxis in metastatic or osteoporotic patients with no evidence of acute fracture ● - . For vertebroplasty/sacroplasty, non-pathological acute traumatic fractures of the vertebra/sacrum - . Displaced sacral fractures - Compromise of the sacral foramina - If sacral surgical fusion may be required ● #### V. Comparison with Predicate Devices The modifications to the SpineJack, Vertaplex Radiopaque Bone Cement, and Vertaplex HV Radiopaque Bone Cement 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>K202393 | 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 | The SpineJack ® Expansion Kit is<br>indicated for use in the reduction | Different - | | Contraindications | 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.<br>They are intended to be used in<br>combination with Stryker<br>Vertaplex® and Vertaplex® HV<br>bone cement. | of painful osteoporotic vertebral<br>compression fractures. It is<br>intended to be used in<br>combination with Stryker<br>Vertaplex and Vertaplex HV bone<br>cements. | Additional<br>indication for<br>traumatic<br>vertebral<br>compression<br>fractures with<br>or without<br>posterior<br>instrumental<br>fixation. | | | 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 | 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 | Identical | | 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 | {9}------------------------------------------------ K211238 Image /page/9/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is black and appears to be the logo for the Stryker Corporation. A thin black line is located underneath the word. {10}------------------------------------------------ K211238 Image /page/10/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is all lowercase. | Element of<br>Comparison | Vertaplex Radiopaque Bone<br>Cement<br>Subject Device | Vertaplex Radiopaque Bone<br>Cement<br>Predicate Device<br>K072118 | Comparison | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory Information Comparison | | | | | Classification | Class II | Class II | Identical | | Regulation | 21 CFR 888.3027…
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