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 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.

Vertaplex® Radiopaque Bone Cement and Vertaplex® High Viscosity (HV) Radiopaque Bone Cement are PMMA bone cements. 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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Stryker SpineJack® Expansion Kit, Vertaplex® Radiopaque Bone Cement, and Vertaplex® High Viscosity (HV) Radiopaque Bone Cement. The submission focuses on seeking an expanded indication for use for traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) in addition to the existing indication for osteoporotic vertebral compression fractures.

Crucially, the document states that "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." This means there isn't a traditional study with a test set, ground truth experts, or an MRMC study as would be seen for a new AI/software-based device.

Instead, the submission relies on 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 acceptance criteria are not in the form of specific performance metrics (e.g., sensitivity, specificity, F1-score) for an AI or diagnostic algorithm, but rather a demonstration that the expanded indication (traumatic VCFs) does not introduce new safety or effectiveness concerns compared to the existing indication (osteoporotic VCFs).

Therefore, a table of acceptance criteria and reported device performance in the typical sense for a diagnostic device (e.g., AI performance metrics) cannot be extracted from this document as the criteria are based on equivalence in safety and effectiveness for an expanded indication of a physical medical device.

However, I can describe the justification for the expanded indication based on the information provided:

1. Acceptance Criteria and Reported Device "Performance":

The acceptance criteria here are qualitative, focusing on the absence of new safety or effectiveness concerns for the expanded indication.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary from RWE)
No different types of questions related to safety or effectiveness for SpineJack/cement when used for traumatic VCFs vs. osteoporotic VCFs.	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.
Safety profile for SpineJack/cement for use in painful osteoporotic VCFs and for traumatic VCFs is nearly the same.	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.	No different types of adverse events are seen in trauma as compared to osteoporosis.
Those adverse events common to both indications (e.g., cement leakage) occur at similar rates.	Those adverse events that they have in common (cement leakage) occur at similar rates.
Device is safe and effective for its intended use and indications for use.	The subject devices are safe and effective for their intended use and indications for use.
Difference in indication does not pose different questions of safety or effectiveness.	The difference in indication does not pose different questions of safety or effectiveness.
Proposed devices are at least as safe and effective as the predicate devices for the proposed indications.	The proposed devices are at least as safe and effective as the predicate devices for the proposed indications.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set (Implicit): Not a traditional "test set" for an algorithm. The evidence relies on:
- Outside-of-US clinical data published in the clinical literature: Sample sizes would vary per publication, but specific numbers are not provided in this document.
- A post-market outside-of-US clinical study: Specific sample size is not provided in this document.
Data Provenance: Outside-of-US clinical data. The document states it is "Real World Evidence (RWE)." It does not specify whether the RWE was retrospective or prospective beyond calling the post-market study "clinical data," which could imply prospective elements.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable in the context of this 510(k) submission. The "ground truth" for the RWE would be the clinical outcomes and safety profiles reported in the literature and the post-market study, as adjudicated by the treating physicians and researchers of those respective studies. The document does not detail individual expert qualifications for establishing this "ground truth" for the RWE, as it is leveraging existing clinical data.

4. Adjudication Method for the Test Set:

Not applicable as it's not a diagnostic algorithm test set requiring expert adjudication. The RWE would have its own data collection and analysis methods from the original studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI or imaging interpretation devices to assess human reader performance with and without AI assistance. This submission pertains to a physical medical device (vertebral augment), not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, this is not an algorithm, so a standalone performance study is not applicable.

7. The Type of Ground Truth Used:

The implicit "ground truth" for demonstrating equivalence is based on clinical outcomes and safety profiles observed in published outside-of-US clinical literature and a post-market outside-of-US clinical study. This is an outcomes data approach, focusing on observed adverse events and clinical effectiveness (reduction/fixation of fractures).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "evidence" is based on existing clinical data (RWE) to support an expanded indication for a physical device.

9. How the Ground Truth for the Training Set was Established:

Not applicable as there is no training set for an AI/ML model. The RWE utilized for the submission would have its "ground truth" established through standard clinical and research methodologies for patient diagnosis, treatment, and follow-up in the original studies where the data was collected.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K211238

Device Name SpineJack® Expansion Kit

Indications for Use (Describe)

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)

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Indications for Use

510(k) Number (if known) K211238

Device Name

Vertaplex® Radiopaque Bone Cement

Indications for Use (Describe)

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)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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Indications for Use

510(k) Number (if known) K211238

Device Name Vertaplex® HV Radiopaque Bone Cement

Indications for Use (Describe)

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.

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."

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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

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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

IV. Proposed Indications for Use, Contraindications

SpineJack Expansion Kit

Indications for Use:

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

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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:

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:

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

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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 ofComparison	SpineJack Expansion Kit(SpineJack)Subject Device	SpineJack Expansion Kit(SpineJack)Predicate DeviceK202393	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 ofvertebral compression fractures	Intended for the reduction ofvertebral compression fractures	Identical
Indications for Use	The SpineJack® Expansion Kit isindicated for use in the reduction	The SpineJack ® Expansion Kit isindicated for use in the reduction	Different -
Contraindications	of painful osteoporotic vertebralcompression fractures, andtraumatic vertebral compressionfractures (Type A fracturesaccording to the AO/Magerlclassification) with or withoutposterior instrumental fixation.They are intended to be used incombination with StrykerVertaplex® and Vertaplex® HVbone cement.	of painful osteoporotic vertebralcompression fractures. It isintended to be used incombination with StrykerVertaplex and Vertaplex HV bonecements.	Additionalindication fortraumaticvertebralcompressionfractures withor withoutposteriorinstrumentalfixation.
	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 Usewith Implant	Intended to be used incombination with StrykerVertaplex and Vertaplex HV bonecements	Intended to be used incombination with StrykerVertaplex and Vertaplex HV bonecements	Identical
Technological Comparison
Contact	Implantable	Implantable	Identical

FundamentalScientificTechnology	The Expansion Kit consists of theSpineJack implant and an implantexpander. The implant iscomposed of a deformableelement and a locking tube and ismade from a titanium alloy.	The Expansion Kit consists of theSpineJack implant and an implantexpander. The implant iscomposed of a deformableelement and a locking tube and ismade from a titanium alloy.	Identical
Principal ofOperation	The SpineJack is implanted intothe vertebra after access isestablished and the site isprepared for the implant. It isinserted into the vertebra via thepedicle in a collapsed form, andexpanded in situ, to achievereduction of vertebralcompression fractures. Onceinserted and expanded, PMMAbone cement is injected into thespace around the SpineJack tomaintain the fracture reduction.	The SpineJack is implanted intothe vertebra after access isestablished and the site isprepared for the implant. It isinserted into the vertebra via thepedicle in a collapsed form, andexpanded in situ, to achievereduction of vertebralcompression fractures. Onceinserted and expanded, PMMAbone cement is injected into thespace around the SpineJack tomaintain 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 HeightPost-Expansion(mm)	12.5/17/20	12.5/17/20	Identical
Implant Material	Ti-6Al-4V	Ti-6Al-4V	Identical

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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.

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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 ofComparison	Vertaplex Radiopaque BoneCementSubject Device	Vertaplex Radiopaque BoneCementPredicate DeviceK072118	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 compressionfractures	Fixation of vertebral compressionfractures	Identical
Indications for Use	Vertaplex® Radiopaque BoneCement is indicated for fixation ofpathological fractures of thevertebral body usingvertebroplasty or kyphoplastyprocedures. Painful vertebralcompression fractures may resultfrom osteoporosis, benign lesions(hemangioma), and malignantlesions (metastatic cancers,myeloma).When used in conjunction withSpineJack® Expansion Kit,	Vertaplex Radiopaque BoneCement is indicated for fixation ofpathological fractures of thevertebral body usingvertebroplasty or kyphoplastyprocedures. Painful vertebralcompression fractures may resultfrom osteoporosis, benign lesions(hemangioma), and malignantlesions (metastatic cancers,myeloma).	Different -Addition ofindication foruse withSpineJack forfixation ofpathological ornon-pathologicaltraumaticvertebralcompressionfractures
Contraindications
	Vertaplex® Radiopaque BoneCement is also indicated for thefixation of osteoporotic ortraumatic AO/Magerl Type Avertebral compression fractures.Allergies or sensitivity to anyof its chemical components The presence of active orincompletely treated infectionat the site where the bonecement is to be applied Coagulation disorders, orwith severe cardiopulmonarydisease Spinal stenosis (>20% byretropulsed fragments) Vertebral plana (collapse>90%) Compromise of the vertebralbody or the walls of thepedicles For vertebroplasty, unstablevertebral fractures due toposterior involvement Patient clearly improving onmedical therapy Prophylaxis in metastatic orosteoporotic patients with noevidence of acute fracture For vertebroplasty, non-pathological acute traumaticfractures of the vertebra	Allergies or sensitivity to anyof its chemical components The presence of active orincompletely treated infectionat the site where the bonecement is to be applied Coagulation disorders, orwith severe cardiopulmonarydisease Spinal stenosis (>20% byretropulsed fragments) Vertebral plana (collapse>90%) Compromise of the vertebralbody or the walls of thepedicles Unstable vertebral fracturesdue to posterior involvement Patient clearly improving onmedical therapy Prophylaxis in metastatic orosteoporotic patients with noevidence of acute fracture Non-pathological acutetraumatic fractures of thevertebra	Similar –Clarificationthat use ofbone cementforvertebroplasty(using cementalone) fortreatment ofnon-pathologicalacute traumaticfractures orunstablevertebralfractures due toposteriorinvolvementarecontraindicated
Technological Comparison
Contact	Implantable	Implantable	Identical
Principal ofOperation	Powder and liquid components aremixed together so that theypolymerize and form a hardenedacrylic polymer. The mixture is ina pourable and injectable state fora period of time, before it cures toform a hardened structure, capableof long-term load support, boneaugmentation and implantencapsulation in the treatment ofvertebral compression fractures.	Powder and liquid componentsare mixed together so that theypolymerize and form a hardenedacrylic polymer. The mixture is ina pourable and injectable state fora period of time, before it cures toform a hardened structure,capable of long-term load support,bone augmentation and implantencapsulation in the treatment ofvertebral compression fractures.	Identical
Implant Material	Polymethylmethacrylate	Polymethylmethacrylate	Identical
Element ofComparison	Vertaplex HV High ViscosityRadiopaque Bone CementSubject Device	Vertaplex HV High ViscosityRadiopaque Bone CementPredicate DeviceK192818	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 compressionfractures, restoration of integrityof spinal column (with ES2)	Fixation of vertebral compressionfractures, restoration of integrityof spinal column (with ES2)	Identical
Indications for Use	Vertaplex® HV RadiopaqueBone Cement is indicated for thefixation of pathological fracturesof the vertebral body usingvertebroplasty or kyphoplasty. Itis also indicated for the fixation ofpathological fractures of the sacralvertebral body or ala using sacralvertebroplasty or sacroplasty.Painful vertebral compressionfractures may result fromosteoporosis, benign lesions(hemangioma), and malignantlesions (metastatic cancers,myeloma).When used in conjunction withES2® Augmentable SpinalSystem, Vertaplex® HighViscosity (HV) Radiopaque BoneCement is intended to restore theintegrity of the spinal columneven in the absence of fusion for alimited time period in patientswith advanced stage tumorsinvolving the thoracic and lumbarspine in whom life expectancy isof insufficient duration to permitachievement of fusion.Vertaplex® High Viscosity (HV)Radiopaque Bone Cement and theES2® Augmentable SpinalSystem are for use together atspinal levels where the structuralintegrity of the spine is notseverely compromised.When used in conjunction withSpineJack® Expansion Kit,Vertaplex® High Viscosity (HV)Radiopaque Bone Cement is alsoindicated for the fixation of	Vertaplex HV Radiopaque BoneCement is indicated for thefixation of pathological fracturesof the vertebral body usingvertebroplasty or kyphoplasty. Itis also indicated for the fixation ofpathological fractures of the sacralvertebral body or ala using sacralvertebroplasty or sacroplasty.Painful vertebral compressionfractures may result fromosteoporosis, benign lesions(hemangioma), and malignantlesions (metastatic cancers,myeloma).When used in conjunction withES2® Augmentable SpinalSystem, Vertaplex® HighViscosity (HV) Radiopaque BoneCement is intended to restore theintegrity of the spinal columneven in the absence of fusion for alimited time period in patientswith advanced stage tumorsinvolving the thoracic and lumbarspine in whom life expectancy isof insufficient duration to permitachievement of fusion.Vertaplex® High Viscosity (HV)Radiopaque Bone Cement and theES2® Augmentable SpinalSystem are for use together atspinal levels where the structuralintegrity of the spine is notseverely compromised.	DifferentAddition ofindication foruse withSpineJack forfixation ofpathological ornon-pathologicaltraumaticvertebralcompressionfractures

	osteoporotic or traumatic AO/Magerl Type A vertebralcompression 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 contraindicatedAdditionally, clarification is made to specify that use in sacral surgical fusion is contraindicated
Technological Comparison
Contact	Implantable	Implantable	Identical
Principal ofOperation	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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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.

Regulation Number and Section

§ 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.”