(60 days)
no reference devices were used in this submission.
No
The device description and intended use focus on a mechanical implant and bone cement for fracture reduction and fixation. There is no mention of AI or ML in the provided text.
Yes
The device is indicated for the reduction of painful osteoporotic and traumatic vertebral compression fractures and for the fixation of pathological fractures of the vertebral body, sacral vertebral body, or ala, which are therapeutic interventions.
No
This device, the SpineJack® Expansion Kit and associated bone cements, is an implanted system and bone cement used for the reduction and fixation of vertebral compression fractures. Its purpose is interventional (treatment), not diagnostic (identifying a condition).
No
The device description clearly states that the SpineJack® Expansion Kit is an implanted reduction system and is used with bone cement, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The SpineJack® Expansion Kit and the associated bone cements are described as implanted systems used to physically reduce and fixate vertebral compression fractures. They are used within the body to treat a structural issue.
- Lack of Laboratory Testing: The description does not mention any testing of biological samples or analysis performed in a laboratory setting.
- Focus on Mechanical Intervention: The core function of the device is mechanical support and stabilization of fractured vertebrae.
Therefore, the SpineJack® Expansion Kit and the Vertaplex® bone cements fall under the category of implantable medical devices used for surgical intervention, not in vitro diagnostic devices.
N/A
Intended Use / 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® 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.
Product codes (comma separated list FDA assigned to the subject device)
NDN, LOD, PML
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body, sacral vertebral body or ala, thoracic and lumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Real World Evidence (RWE) consisting of outside-of-US clinical data published in the clinical literature and a post-market outside-of-US clinical study. The SpineJack implant was previously tested to be non-pyrogenic.
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 traumatic VCFs. The literature shows that the safety profile for SpineJack/cement for use in painful osteoporotic VCFs and for traumatic VCFs is nearly the same. No different types of adverse events are seen in trauma as compared to 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
no reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
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.(b)
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.”
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) | |
|---|---|
| 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:
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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) | |
|---|---|
| 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."
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
Comparison | SpineJack Expansion Kit
(SpineJack)
Subject Device | SpineJack Expansion Kit
(SpineJack)
Predicate Device
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
vertebral compression fractures | Intended for the reduction of
vertebral compression fractures | Identical |
| Indications for Use | The SpineJack® Expansion Kit is
indicated for use in the reduction | The SpineJack ® Expansion Kit is
indicated for use in the reduction | Different - |
| Contraindications | 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. | of painful osteoporotic vertebral
compression fractures. It is
intended to be used in
combination with Stryker
Vertaplex and Vertaplex HV bone
cements. | Additional
indication for
traumatic
vertebral
compression
fractures with
or without
posterior
instrumental
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
with Implant | Intended to be used in
combination with Stryker
Vertaplex and Vertaplex HV bone
cements | Intended to be used in
combination with Stryker
Vertaplex and Vertaplex HV bone
cements | Identical |
| Technological Comparison | | | |
| Contact | Implantable | Implantable | Identical |
| | | | |
| Fundamental
Scientific
Technology | The Expansion Kit consists of the
SpineJack implant and an implant
expander. The implant is
composed of a deformable
element and a locking tube and is
made from a titanium alloy. | The Expansion Kit consists of the
SpineJack implant and an implant
expander. The implant is
composed of a deformable
element and a locking tube and is
made from a titanium alloy. | Identical |
| Principal of
Operation | The SpineJack is implanted into
the vertebra after access is
established and the site is
prepared for the implant. It is
inserted into the vertebra via the
pedicle in a collapsed form, and
expanded in situ, to achieve
reduction of vertebral
compression fractures. Once
inserted and expanded, PMMA
bone cement is injected into the
space around the SpineJack to
maintain the fracture reduction. | The SpineJack is implanted into
the vertebra after access is
established and the site is
prepared for the implant. It is
inserted into the vertebra via the
pedicle in a collapsed form, and
expanded in situ, to achieve
reduction of vertebral
compression fractures. Once
inserted and expanded, PMMA
bone cement is injected into the
space around the SpineJack to
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-
Expansion (mm) | 4.2/5.0/5.8 | 4.2/5.0/5.8 | Identical |
| Maximum Height
Post-Expansion
(mm) | 12.5/17/20 | 12.5/17/20 | Identical |
| Implant Material | Ti-6Al-4V | Ti-6Al-4V | Identical |
9
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
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
Comparison | Vertaplex Radiopaque Bone
Cement
Subject Device | Vertaplex Radiopaque Bone
Cement
Predicate Device
K072118 | Comparison |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information Comparison | | | |
| Classification | Class II | Class II | Identical |
| Regulation | 21 CFR 888.3027 | 21 CFR 888.3027 | Identical |
| Product Code | NDN, LOD | NDN, LOD | Identical |
| Panel | Orthopedic | Orthopedic | Identical |
| Intended Use and Indications for Use Comparison | | | |
| Intended Use | Fixation of vertebral compression
fractures | Fixation of vertebral compression
fractures | Identical |
| 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 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). | Different -
Addition of
indication for
use with
SpineJack for
fixation of
pathological or
non-
pathological
traumatic
vertebral
compression
fractures |
| Contraindications | | | |
| | Vertaplex® Radiopaque Bone
Cement is also indicated for the
fixation of osteoporotic or
traumatic AO/Magerl Type A
vertebral compression fractures.
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 | 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 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 Non-pathological acute
traumatic fractures of the
vertebra | Similar –
Clarification
that use of
bone cement
for
vertebroplasty
(using cement
alone) for
treatment of
non-
pathological
acute traumatic
fractures or
unstable
vertebral
fractures due to
posterior
involvement
are
contraindicated |
| Technological Comparison | | | |
| Contact | Implantable | Implantable | Identical |
| Principal of
Operation | Powder and liquid components are
mixed together so that they
polymerize and form a hardened
acrylic polymer. The mixture is in
a pourable and injectable state for
a period of time, before it cures to
form a hardened structure, capable
of long-term load support, bone
augmentation and implant
encapsulation in the treatment of
vertebral compression fractures. | Powder and liquid components
are mixed together so that they
polymerize and form a hardened
acrylic polymer. The mixture is in
a pourable and injectable state for
a period of time, before it cures to
form a hardened structure,
capable of long-term load support,
bone augmentation and implant
encapsulation in the treatment of
vertebral compression fractures. | Identical |
| Implant Material | Polymethylmethacrylate | Polymethylmethacrylate | Identical |
| Element of
Comparison | Vertaplex HV High Viscosity
Radiopaque Bone Cement
Subject Device | Vertaplex HV High Viscosity
Radiopaque Bone Cement
Predicate Device
K192818 | Comparison |
| Regulatory Information Comparison | | | |
| Classification | Class II | Class II | Identical |
| Regulation | 21 CFR 888.3027 | 21 CFR 888.3027 | Identical |
| Product Code | NDN, PML | NDN, PML | Identical |
| Panel | Orthopedic | Orthopedic | Identical |
| Intended Use and Indications for Use Comparison | | | |
| Intended Use | Fixation of vertebral compression
fractures, restoration of integrity
of spinal column (with ES2) | Fixation of vertebral compression
fractures, restoration of integrity
of spinal column (with ES2) | Identical |
| 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, 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
SpineJack® Expansion Kit,
Vertaplex® High Viscosity (HV)
Radiopaque Bone Cement is also
indicated for the fixation of | 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, 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. | Different
Addition of
indication for
use with
SpineJack for
fixation of
pathological or
non-
pathological
traumatic
vertebral
compression
fractures |
| | | | |
| | 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 | 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 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 Non-pathological, acute traumatic fractures of the vertebra/sacrum Displaced sacral fractures Compromise of the sacral foramina If surgical fusion may be required | Similar –
Clarification that use of bone cement for sacroplasty or vertebroplasty (using cement alone) for treatment of non-pathological acute traumatic fractures or for unstable vertebral fractures due to posterior involvement are contraindicated
Additionally, clarification is made to specify that use in sacral surgical fusion is contraindicated |
| Technological Comparison | | | |
| Contact | Implantable | Implantable | Identical |
| Principal of
Operation | Powder and liquid components are mixed together so that they polymerize and form a hardened acrylic polymer. The mixture is in a pourable and injectable state for a period of time, before it cures to form a hardened structure, capable of long-term load support, bone augmentation and implant encapsulation in the treatment of vertebral compression fractures. | Powder and liquid components are mixed together so that they polymerize and form a hardened acrylic polymer. The mixture is in a pourable and injectable state for a period of time, before it cures to form a hardened structure, capable of long-term load support, bone augmentation and implant encapsulation in the treatment of vertebral compression fractures. | Identical |
| Implant Material | Polymethylmethacrylate | Polymethylmethacrylate | Identical |
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Image /page/11/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and black. The word is centered and takes up most of the image space.
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Image /page/12/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase and black. The background is white.
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Image /page/13/Picture/0 description: The image shows the alphanumeric string "K211238". The string is written in a simple, sans-serif font. The characters are black against a white background, providing high contrast and readability.
Image /page/13/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 written in all lowercase letters.
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Image /page/14/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. The image appears to be a logo or product identifier.
VI. Performance Data
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 Real World Evidence (RWE) consisting of outside-of-US clinical data published in the clinical literature and a post-market outside-of-US clinical study. The SpineJack implant was previously tested to be non-pyrogenic.
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 of reduction/fixation of osteoporotic VCF are a subset of the intended use. Therefore, the subject devices have the same intended use as the predicates.
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 traumatic VCFs. The literature shows that the safety profile for SpineJack/cement for use in painful osteoporotic VCFs and for traumatic VCFs is nearly the same. No different types of adverse events are seen in trauma as compared to 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 the reduction of traumatic vertebral compression fractures. Therefore, a decision of substantial equivalence is supported.