VertaPlex® HV High Viscosity 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 sacroplasty 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® HV High Viscosity 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® HV High Viscosity 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 without cement, the ES2® Augmentable Spinal System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with the Vertaplex® HV High Viscosity Radiopaque Bone Cement, the ES2® Augmentable Spinal System 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. ES2® Augmentable Spinal System augmented with the Vertaplex® HV High Viscosity Radiopaque Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

Device Description

VertaPlex® HV High Viscosity Radiopaque Bone Cement is bone cement comprised of a liquid component and powder component which when mixed together polymerize to form a hardened acrylic polymer. The mixture is in an injectable state for a period of time before it cures to form a hardened structure, capable of long-term load support and bone augmentation in the treatment of symptomatic osteoporotic vertebral compression fractures.

The powder component of VertaPlex® HV High Viscosity Radiopaque Bone Cement is Ethylene Oxide (EO) sterilized and is packaged in a polyethylene/foil pouch while the liquid monomer is aseptically filled into an amber glass ampoule which is EO sterilized. The device contains the following components: Polymer powder, Monomer liquid and Barium Sulfate. Accessories to the subject cement device are compatible Stryker cement mixers such the Stryker Autoplex System and the Stryker PCD System.

ES2® Augmentable Spinal System is a gamma sterilized, titanium implantable screw with fenestrations and blocker designed as a stabilization solution for the aging spine. The subject system (screw and blocker) has been developed to provide improved anchorage of pedicle screws with and without Vertaplex® HV High Viscosity Radiopaque Bone Cement during pedicle screw augmentation in vertebrae with reduced bone quality as compared to pedicle screw augmentation in healthy bone.

AI/ML Overview

The provided text is a 510(k) summary for the Stryker Vertaplex® HV High Viscosity Radiopaque Bone Cement and ES2® Augmentable Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technological characteristics, rather than presenting a study proving a device meets specific acceptance criteria based on its performance in a clinical or analytical setting.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is largely not present in this type of FDA submission.

Here's what can be extracted and inferred based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document states: "The subject devices were tested and met all respective acceptance criteria as specified per the individual test report." and "The acceptance criteria for the subject device were similar to the acceptance criteria for the Stryker predicate device." However, the specific acceptance criteria and detailed performance metrics are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily refers to "Bench" testing and "cadaver validation."

Sample Size: Not specified for any particular test.
Data Provenance: Implied to be in-house testing by Stryker Instruments, likely in the USA given the company's address. The testing is non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "tests" mentioned are physical/mechanical bench tests and cadaver validation, not diagnostic or clinical assessments requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no expert-based ground truth establishment or adjudication is described.

5. 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, an MRMC study was not done. This device is a bone cement and a spinal system, not an AI-powered diagnostic tool. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." It does mention a "clinical literature review" to support safety and effectiveness of PMMA bone cement with augmentable pedicle screws, but this is a review of existing literature, not a new comparative effectiveness study.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical bench testing, the "ground truth" would be the established engineering and materials science standards (e.g., ASTM F1798-12, ASTM F1717-12, ANSI/AAMI ST72:2011(R2016), ISO 11137-2:2013, ASTM F1980, ISO 11607) that define acceptable performance for device characteristics like static strength, pullout force, sterility assurance, endotoxin limits, and shelf life.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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Build Correspondence

Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

March 31, 2020

Stryker Corporation Kristi Ashton Sr Staff Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K192818

Trade/Device Name: Vertaplex HV High Viscosity Radiopaque Bone Cement, ES2® Augmentable Spinal System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: PML, NKB, NDN Dated: September 30, 2019 Received: October 1, 2019

Dear Kristi Ashton:

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 medical devices and radiation-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,

Jesse Muir, PhD Acting 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) K192818

Device Name

Vertaplex® HV High Viscosity Radiopaque Bone Cement

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)

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."

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Indications for Use

510(k) Number (if known) K192818

Device Name ES2 ® Augmentable Spinal System

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)

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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510(k) Number: K192818 Date Submitted: March 26, 2020

Traditional 510(k)

Stryker Instruments 4100 East Milham Ave, Kalamazoo, MI 49001 USA

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stryker®

Instruments

510k Summary

1. Submitter

Stryker Instruments 4100 East Milham Avenue Kalamazoo, MI 49001 Phone +1 (269) 323-7700 Fax +1 (269) 324-5412

FDA Establishment Registration Number: 1811755

Contact:

Kristi Ashton Stryker Instruments Regulatory Affairs Sr. Staff Regulatory Affairs Specialist Phone: +1 (269) 800-1692 Kristi.Ashton@Stryker.com

Date Submitted: March 26, 2020

2. Subject Devices

Trade Name: Vertaplex ® HV High Viscosity Radiopaque Bone Cement Common Name: Polymethylmethacrylate (PMMA) Bone Cement Product Codes: PML, NDN Regulation: 21CFR888.3027

Trade Name: ES2® Augmentable Spinal System Common Name: Thoracolumbosacral pedicle screw system Product Codes: NKB Regulation: 21CFR888.3070

Predicate Device (Cement)
Kyphon Xpede BoneCement/Medtronic HV Bone Cement	K171938	NDN, PML	21CFR888.3027
Predicate Device (Screw Systems)
CD Horizon Fenestrated Screw Set(Primary)	K171938	MNI	21CFR888.3070
ES2® Spinal System (Secondary)	K122845	NKB, KWP, MNH, MNI	21CFR888.3070

3. Legally Marketed Predicate Device(s)

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Stryker Instruments 4100 East Milham Ave, Kalamazoo, MI 49001 USA

4. Device Description

5. Intended Use/Indications for use

VertaPlex® HV High Viscosity Radiopaque Bone Cement:

VertaPlex® HV High Viscosity 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® HV High Viscosity 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® HV High Viscosity 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.

ES2® Augmentable Spinal System:

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Instruments

the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with the VertaPlex® HV High Viscosity Radiopaque Bone Cement, the ES2® Augmentable Spinal System 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. ES2® Augmentable Spinal System augmented with the Vertaplex® HV Radiopaque Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

6. Comparison of Technological Characteristics with the Predicate Device

The Stryker Vertaplex® HV High Viscosity Radiopaque Bone Cement has not changed since it was cleared via K150582 and has the same intended use, principle of operation, and mode of action as the predicate devices. In addition, Vertaplex® HV High Viscosity Radiopaque Bone Cement and Kyphon Xpede Bone cement were previously determined to be substantially equivalent per K163032.

The Stryker ES2® Augmentable Spinal System has the same intended use as the predicate devices. The majority of the technical characteristics are similar/identical to the predicate devices K171938 CD Horizon Fenestrated Screw System and the secondary predicate K122845 ES2®Spinal System with a few exceptions such as added fenestrations and overall sterility. These differences have been found through testing, clinical literature, and a risk analysis to be insignificant and do not raise new questions of safety and effectiveness.

7. Non-Clinical

Bench

Static testing and interconnection strength testing were completed according to ASTM F1798-12 and Static pullout was performed per ASTM F1717-12. In addition, cadaver validation was performed. The subject devices were tested and met all respective acceptance criteria as specified per the individual test report. The testing was conducted in as similar a manner as possible to the clinical setting using the final finished form of the device. The acceptance criteria for the subject device were similar to the acceptance criteria for the Stryker predicate device. The performance testing further demonstrates equivalence because the subject device is shown to have equivalent functional characteristics as the predicate device.

Sterilization and Shelf Life

Vertaplex® HV Radiopaque Bone Cement will be sterilized per the same ETO methodology and dosage as was listed in submission K091606. The shelf life of 36 months for the subject cement has not been modified since submission K150582. The Vertaplex® HV Radiopaque Bone cement has been tested for bacterial endotoxins using

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Image /page/7/Picture/10 description: The image shows the Stryker logo with the word "Instruments" written below it. Above the logo, the text "K192818" and "Page 4 of 5" are printed. The Stryker logo is in bold, black font, and the word "Instruments" is in a smaller, bold, black font.

Stryker Instruments 4100 East Milham Ave, Kalamazoo, MI 49001 USA

Limulus amebocyte lysate (LAL) reagent and kinetic-turbidimetric methodology per ANSI/AAMI ST72:2011(R2016). The endotoxin limits for the Vertaplex® HV Radiopaque Bone Cement are <2.15 EU/device, as recommended for devices that have the potential to unintentionally extravasate out of the vertebral body, contact the cerebrospinal fluid or the circulatory system, resulting in exposure.

The ES2® Augmentable Spinal System is sterilized by gamma irradiation in accordance with AAMI guidelines and ISO 11137-2:2013 "Sterilization of health care products -Radiation - Part 2 to achieve sterility assurance level of 10-6. Additionally, the ES2® Augmentable Spinal System has been tested for bacterial endotoxins using Limulus amebocyte lysate (LAL) reagent and kinetic-turbidimetric methodology per ANSVAAMI ST72:2011(R2016). The endotoxin limits for the ES2® Augmentable Spinal System are <20 EU/device, as recommended for devices that are not intended to contact the cerebrospinal fluid.

ES2® Augmentable Spinal System has a shelf life of 5 years based on aging studies leveraged from the Stryker Spine Thoracolumbar (TL) Portfolio. This testing was completed for all packaging assemblies of TL System (Real Time and Accelerated Aging) in accordance with ASTM F1980 and ISO 11607.

Biocompatibility

The materials, processes and sterilization methodology for Vertaplex® HV Radiopaque Bone Cement are identical to that which was cleared in the original Vertaplex® HV submission K091606. Vertaplex® HV Radiopaque Bone Cement remains a biocompatible device.

The grade of material used by Stryker to manufacture the ES2® Augmentable Spinal System are ASTM F136 and ISO 5832 recommended. Since, the material has repetitively undergone traditional manufacturing processes and are documented as having a long history of use substantiated with supporting data from testing and literature citations, it was deemed unnecessary to conduct additional testing as allowed per FDA Guidance on ISO 10993. A biological risk assessment was completed and supported by information on the ES2® Augmentable Spinal System materials of construction, manufacturing processes/aids, gathered toxicological data on these materials, biological/chemical evaluation of equivalent devices, as well as other available literature. Based upon examination of this information, the risk assessment indicates that the risk of a toxic effect from the ES2® Augmentable Spinal System is negligible and that the devices can be considered safe for use as intended.

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Stryker Instruments 4100 East Milham Ave, Kalamazoo, MI 49001 USA

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8. Clinical

No clinical testing was deemed necessary for this 510(k).

A clinical literature review has been completed to support this pre-market notification. The clinical literature review provides evidence to support the safety and effectiveness of the use of PMMA bone cement with augmentable pedicle screws systems.

9. Substantial Equivalence Conclusion

Based upon the non-clinical testing completed and additional supporting documentation provided in this pre-market submission, the subject cement device and screw system have demonstrated safety and effectiveness. Based on the information provided, it can be concluded that the subject cement device. Vertaplex® HV High Viscosity Radiopaque Bone Cement, is substantially equivalent to the predicate cement devices, K171938 Kyphon Xpede Bone Cement/Medtronic HV Bone Cement; and the subject screw system, ES2® Augmentable Spinal System, is substantially equivalent to the predicate screw systems, K171938 CD Horizon Fenestrated Screw System and K122845 ES2® Spinal System.

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.”