The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures, traumatic vertebral compression fractures according to the AO/Magerl classification) with or without posterior instrumental fixation, and compression from malignant lesions (myeloma or osteolytic metastasis). It is intended to be used in combination with Stryker Vertaplex HV bone cement.

Device Description

The SpineJack® Expansion Kit ("SpineJack") is an implanted reduction system intended to reduce vertebral compression fractures. The SpineJack is used with a Preparation Kit (sold separately) which prepares the vertebra for implant. The SpineJack is available in three sizes to accommodate different vertebral body sizes, specifically 4.2 mm, 5 mm, and 5.8 mm. After the implant is inserted, it is expanded to reduce the vertebral compression fracture and Vertaplex Radiopaque Bone Cement, or Vertaplex HV Radiopaque Bone Cement (sold separately) is injected at low pressure to fixate the restored vertebral body.

AI/ML Overview

The provided FDA 510(k) clearance document for the Stryker SpineJack® Expansion Kit (K223294) describes the device's indications for use and compares it to a predicate device (K211238). It states that no new performance data was generated for the submission as the modification concern only the indications for use and associated labeling; no physical device modifications were made. Therefore, the information provided focuses on the safety and effectiveness of the device for expanded indications based on existing clinical literature and real-world evidence.

Here's an attempt to structure the information based on your request, though it's important to note that a traditional "acceptance criteria" table with specific device performance metrics in the format you requested is not provided in this regulatory document, as it relies on substantial equivalence to a predicate and real-world evidence for an expanded indication. The document focuses on demonstrating that the safety and effectiveness profile for the new indication (malignant lesions) is comparable to the existing indications.

Acceptance Criteria and Device Performance (Interpreted from Clinical Literature Review)

The document does not present explicit numerical "acceptance criteria" for the device's performance in the context of a new study designed to meet specific thresholds for this 510(k) submission. Instead, it leverages existing clinical literature and real-world evidence (RWE) to demonstrate that the safety and effectiveness profile of the SpineJack system for malignant vertebral compression fractures is comparable to its use in osteoporotic and traumatic fractures, which were previously cleared.

The implicit "acceptance criteria" are derived from the observed safety profile (e.g., adverse event rates, particularly cement leakage) and effectiveness outcomes (e.g., pain reduction, quality of life improvement) reported in the analyzed literature for both the newly sought indication and the existing cleared indications.

Acceptance Criteria Category (Implicit)	Reported Device Performance (from literature review)
Safety Profile Similarity (Malignant vs. Osteoporotic/Traumatic VCFs)	The literature shows that the safety profile for SpineJack/cement for use in painful osteoporotic VCFs, traumatic VCFs, and malignant lesions (myeloma or osteolytic metastasis) VCFs is nearly the same. No different types of adverse events are seen in malignant lesions (myeloma or osteolytic metastasis) as compared to trauma or osteoporosis. Those adverse events that they have in common (e.g., cement leakage) occur at similar rates.
Pain Improvement (for malignant VCFs)	Across all studies, there was statistically significant pain improvement with sustained long-term relief as measured by the Visual Analogue Scale (VAS). This decrease in pain occurred regardless of treatment details or concomitant procedures and was found to persist for up to 5 years after the initial treatment. The data demonstrated that the SpineJack system is an effective treatment option, notably for pain relief, in treating malignant spinal tumors.
Quality of Life Improvement (for malignant VCFs)	The studies found that the SpineJack system can not only reduce pain but also improve the quality of life for this patient cohort, as demonstrated by the EQ-5D VAS and Oswestry Disability Index.
Benefit/Risk Ratio	All potential risks were noted and evaluated specifically with regard to an acceptable benefit/risk ratio. (This is a qualitative assessment based on the overall safety and effectiveness findings.)

Study Details Proving Acceptance Criteria (Derived from Literature Review and RWE)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The submission relied on a literature review which included evidence on 304 patients who received the SpineJack System across various studies. Of these, 117 patients were treated specifically for malignant vertebral fractures, which is the focus of the expanded indication.
- Data Provenance: The data was retrospective, collected from an analysis of existing clinical publications and Real-World Evidence (RWE). The studies took place in Spain, France, Switzerland, and in the United States.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts involved in establishing the ground truth for the test set within the context of this 510(k) submission. Since it's a literature review, the "ground truth" for the reported outcomes (e.g., pain, adverse events) would have been established by the clinicians and researchers involved in the original studies themselves. The submission's "experts" would be the regulatory and clinical review staff at Stryker who analyzed the literature.
Adjudication method for the test set:
- The document does not describe an adjudication method for a test set in the traditional sense of a new clinical trial. The data was collected from existing publications, implying that the outcomes reported in those publications were accepted as presented.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was performed. This device is a physical implantable reduction system, not an AI or imaging-based diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The SpineJack is a physical medical device, not a standalone algorithm.
The type of ground truth used:
- The ground truth for the effectiveness outcomes (pain, quality of life) and safety outcomes (adverse events, including cement leakage) was established through clinical outcomes data reported in peer-reviewed literature and real-world evidence from clinical practice. This includes patient-reported outcomes (VAS, EQ-5D VAS, Oswestry Disability Index) and objective clinical observations of adverse events.
The sample size for the training set:
- Not applicable in the context of this 510(k) submission. This submission relies on a literature review and RWE for expanded indications, not a machine learning model that would require a distinct training set. The "training" for the device's original clearance and subsequent clinical use would have come from the broader body of medical knowledge and clinical experience for comparable devices and procedures.
How the ground truth for the training set was established:
- Not applicable. As explained above, there is no "training set" in the machine learning sense for this device submission.

Summary

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December 20, 2022

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Stryker Instruments Bruce Backlund Principal Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002

Re: K223294

Trade/Device Name: SpineJack® Expansion Kit Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN Dated: October 25, 2022 Received: October 26, 2022

Dear Bruce Backlund:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sara S. Thompson -S

For

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223294

Device Name SpineJack® Expansion Kit

Indications for Use (Describe)

The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures, traumatic vertebral compression fractures according to the AO/Mager! classification) with or without posterior instrumental fixation, and compression from malignant lesions (myeloma or osteolytic metastasis). It is intended to be used in combination with Stryker Vertaplex HV bone cement.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Submitter

Stryker Instruments 1941 Stryker Way Portage, MI 49002

Contact

Bruce Backlund Principal Regulatory Affairs Specialist Ph: 763.762.5902 email: bruce.backlund(@stryker.com Date Prepared: 19 December 2022

I. Devices

Brand Name: SpineJack® Expansion Kit Common Name: Implantable Fracture Reduction System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: II Product Code: NDN - Cement, Bone, Vertebroplasty

II. Predicate Devices

SpineJack® Expansion Kit, K211238

The predicate has not been subject to a design-related recall, and no reference devices were used in this submission.

III. Device Description

IV. Proposed Indications for Use, Contraindications

Indications for Use:

SpineJack® Expansion Kit

The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic

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vertebral compression fractures, traumatic vertebral compression fractures according to the AO/Magerl classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). It is intended to be used in combination with Stryker Vertaplex and Vertaplex HV bone cement.

Contraindications:

The SpineJack device is not indicated for any application other than that for which the device is designed.

The list of contraindications given below is not limited. Refer to the instructions for use of the PMMA cement used in combination with the SpineJack implant.

Patient presenting with non-mobile fractures
Sclerotic fracture or fracture not showing a pseudarthrosis ●
Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement
Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the ● time of surgery or at least 8 days prior to inclusion
Active infection (systemic or in the target vertebra)
Patient suffering from a severe or uncontrolled systemic disease
Patient presenting neurological damage caused by vertebral fracture ●
Patient pregnant or likely to be so or breastfeeding ●
Patient vertebral anatomy not compatible with the size of the implant or instrumentation
Fracture geometry making the insertion of the implant impossible
Patients presenting with type B or C traumatic vertebral fractures according to the Magerl . classification

V. Comparison with Predicate Device

The modification to the SpineJack concern the indications for use and resulting labeling only. No modifications were required of the physical device. Therefore, mechanical design, materials, sizes, packaging, sterilization, user profile, and use environment are identical.

Element ofComparison	SpineJack Expansion Kit(SpineJack)Subject Device	SpineJack Expansion Kit(SpineJack)Predicate DeviceK211238	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 reductionof painful osteoporoticvertebral compression fractures,traumatic vertebral compressionfractures (Type A fracturesaccording to the AO/Magerlclassification) with or withoutposterior instrumental fixation,and compression fractures thatresult from malignant lesions(myeloma or osteolyticmetastasis). It is intended to beused in combination with StrykerVertaplex and Vertaplex HV bonecement.	The SpineJack Expansion Kit isindicated for use in the reductionof painful osteoporotic vertebralcompression fractures, andtraumatic vertebral compressionfractures (Type A fracturesaccording to the AO/Magerlclassification) with or withoutposterior instrumental fixation. Itis intended to be used incombination with StrykerVertaplex and Vertaplex HV bonecement.	Different -additionalindication forcompressionfractures thatresultfrom malignantlesions(myelomaor osteolyticmetastasis)
Contraindications	Patient presenting with non-mobile fractures Patients presenting with Type B or C traumatic vertebral fractures according to the Magerl Classification. Sclerotic fracture or fracture not showing a pseudarthrosis Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the time of surgery or at least 8 days prior to inclusion Active infection (systemic or in the target vertebra) Patient suffering from a severe or uncontrolled systemic disease Patient presenting neurological damage caused by vertebral fracture Patient pregnant or likely to be so or breastfeeding Patient vertebral anatomy not compatible with the size of the implant or instrumentation Fracture geometry making the insertion of the implant impossible	Patient presenting with non-mobile fractures Patients presenting with Type B or C traumatic vertebral fractures according to the Magerl Classification. Patients presenting with tumoral fractures Sclerotic fracture or fracture not showing a pseudarthrosis Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the time of surgery or at least 8 days prior to inclusion Active infection (systemic or in the target vertebra) Patient suffering from a severe or uncontrolled systemic disease Patient presenting neurological damage caused by vertebral fracture Patient pregnant or likely to be so or breastfeeding Patient vertebral anatomy not compatible with the size of the implant or instrumentation Fracture geometry making the insertion of the implant impossible	Similar-The subjectdeviceis proposing theremoval of:Patientspresenting withtumoralfractures asthey don't meetthe definition ofacontraindicationand thissubmission isseeking aclearedindication fortumoralfractures (i.e.fractures causedby malignantlesions such asmyeloma orosteolyticmetastasis).
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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Performance Data VI.

No bench or biocompatibility testing was required to support the proposed indications. Additionally, no prospective clinical data was generated for the purpose of supporting this submission. The proposed indications are supported by clinical data collected from Literature and Real-World Evidence (RWE).

Literature summary: Relevant publications were thoroughly analyzed to determine the safety and effectiveness of the SpineJack system for use for treatment of malignant, spinal bone tumors. The literature shows that the safety profile for SpineJack/cement for use in painful osteoporotic VCFs, traumatic VCFs and malignant lesions (myeloma or osteolytic metastasis) VCFs is nearly the same. No different types of adverse events are seen in malignant lesions (myeloma or osteolytic metastasis) as compared to trauma or osteoporosis, and those adverse events that they have in common (cement leakage) occur at similar rates. All potential risks were noted and evaluated specifically with regard to an acceptable benefit/risk ratio. Across all studies there was statistically significant pain improvement with sustained long-term relief as measured by the Visual Analogue Scale (VAS). This decrease in pain occurred regardless of the treatment details or concomitant procedures performed and was found to persist for up to 5 years after the initial

Kor

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treatment. It was found in these studies that the SpineJack system can not only reduce pain but also improve the quality of life for this patient cohort demonstrated by the EO5 VAS and Oswestry Disability Index. The data demonstrated that the SpineJack system is an effective treatment option, notably for pain relief, in treating malignant spinal tumors.

Patient Demographics: The studies provided evidence on 304 patients who received SpineJack System, of which 117 were treated for malignant vertebral fractures. These studies took place in Spain, France, Switzerland and in the United States. The age range of patients was between 23 to 90 years of age with the mean age in all studies recorded above 62 years. Of the 304 patients 136 were male (45%) and 166 (55%) were female. Body mass index was recorded in two studies as 26.0 ± 4.6 kg/m2 and 28.8 ± 5.8kg/m2. The one study in the United States reported on ethnicity with 70% of the study being Caucasian, and the ethnicity of the remaining 30% was not documented. EU regulations do not permit collection of race or ethnicity data however, no race or ethnic group were excluded based on exclusion criteria in any study. Fractures were located from T6 to L4, with the thoracolumbar junction the most affected area. The patients had a wide range of primary tumor locations including but not limited to breast, lung, ovarian, kidney, melanoma and gastrointestinal.

VII. Conclusion

The evidence provided within this submission supports that the proposed indications are a subset of the intended use of the predicate (reduction/fixation of vertebral compression fractures), just as the predicate indications painful osteoporotic vertebral compression fractures, and traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation are a subset of the intended use. Therefore, the subject device has the same intended use as the predicate.

The characteristics described above in the Performance Data section are consistent with the US malignant, spinal bone tumor population. The average age of patients affected by secondary spinal tumors is 55 - 60 years 1. Furthermore, many of the primary tumors mentioned above affect persons of increased age, with 60% of cancer patients over 65 years of age2 which is in line with the population captured here. Additionally, the information from these studies does include information on a patient cohort from the United States. This study included 30 patients (n=19 for tumor indication) of which 12 patients were male and 18 were female, with a mean age of 62.7 (±12.8) and fractures located from 77 to L4, with most fractures occurring at T12 and L1.

United States census population estimates in July 2021 reported that more than 70% of Americans are in the ethnic group of "White alone"3. In the 2010 census more than 70% of Americans were in the ethnic group of "White/ Caucasian Americans"4. According to U.S. Office of Management and Budgets, "White" refers to a person having origins in any of the original peoples of Europe, the Middle East, or North Africa4. The EU Statistics on migration to Europe (2022) reports that 5.3% of all residents come from outside the European Union (EU) and 8.4% of residents were born outside of the EU5, further demonstrating that the current EU

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population is not homogeneous. Therefore, any clinical data stemming from the European population are fully transferrable to the American population.

The RWE provided demonstrates that there are not different types of questions related to safety or effectiveness when SpineJack/cement are used for reduction/fixation of malignant lesions (myeloma or osteolytic metastasis) VCFs. The literature shows that the safety profile for SpineJack/cement for use in painful osteoporotic VCFs, traumatic VCFs and malignant lesions (myeloma or osteolytic metastasis) VCFs is nearly the same. No different types of adverse events are seen in malignant lesions (myeloma or osteolytic metastasis) as compared to trauma or osteoporosis, and those adverse events that they have in common (cement leakage) occur at similar rates. The subject devices are safe and effective for their intended use and indications for use.

The intended use is the same as the predicate, and the difference in indication does not pose different questions of safety or effectiveness. The proposed devices are at least as safe and effective as the predicate devices for the proposed indications. The technological characteristics are identical between subject and predicate, as no physical design changes were required to allow for use in malignant lesions (myeloma or osteolytic metastasis) vertebral compression fractures. Therefore, a decision of substantial equivalence is supported.

References:

Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-1. Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7. PMID: 10735013
SEER Cancer Statistics Review 1975-2000, National Cancer Institute. Retrieved from 2. https://seer.cancer.gov/archive/csr/1975-2000/
1. Retrieved from https://www.census.gov/quickfacts/fact/table/US/PST045221. Accessed on December 13th, 2022.
Retrieved from 4. https://www.census.gov/content/dam/Census/library/publications/2011/dec/c2010br-05.pdf Accessed on December 14th, 2022
Retrieved from https://commission.europa.eu/strategy-and-policy/priorities-2019-5. 2024/promoting-our-european-wav-life/statistics-migration-europe en Accessed on December 14th, 2022

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.”