VertaPlex HV Radiopaque Bone Cement is indicated for the fixation of patholoqical fractures of the vertebral body usinq 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).

Device Description

VertaPlex® HV Radiopaque Bone Cement is comprised of a liquid component and powder component which when mixed together polymerize to 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 and bone augmentation in the treatment of symptomatic osteoporotic vertebral compression fractures.

The powder component of VertaPlex® HV Radiopaque Bone Cement is EO(Ethylene Oxide) 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 (14g), Monomer liquid (9.5ml), and Barium Sulfate (6g

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Stryker® VertaPlex® High Viscosity (HV) Radiopaque Bone Cement. The submission seeks to expand the indications for use of the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: This submission is for an expanded indication for a previously cleared device. The focus of the "study" is to demonstrate safe use in the expanded anatomical area (sacrum) and procedure (sacroplasty), primarily concerning the risk of cement extravasation, rather than proving the overall effectiveness of the bone cement for fracture fixation. The primary comparator is the predicate device, and the demonstration of substantial equivalence relies heavily on the fact that the underlying technology and composition remain unchanged.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of quantitative acceptance criteria for device performance. Instead, the "acceptance criteria" are implied by demonstrating that the expanded indications for use, particularly for the sacrum and sacroplasty, do not introduce new safety or effectiveness concerns, specifically regarding extravasation. The general acceptance criterion is demonstrating substantial equivalence to the predicate device, meaning the new indication is as safe and effective as the predicate.

Acceptance Criterion (Implied)	Reported Device Performance (as demonstrated by cadaveric study)
Mitigation of extravasation risk for sacroplasty procedures (specifically in the sacrum using long-axis and short-axis techniques)	"No instances of cement extravasation after administration of VertaPlex HV Radiopaque Bone Cement were observed in the cadavers included in this study, using the long-axis technique or the short-axis technique."
	"The results of this cadaveric study demonstrate no difference in the occurrence of cement extravasation after administration of VertaPlex HV Radiopaque Cement between the long- and short-axis techniques when the sacroplasty procedure is performed with meticulous imaging guidance by a physician who is trained and experienced in vertebral augmentation and acetabuloplasty and when careful post-procedural positioning is used."
Establishment of surgical guidelines to mitigate extravasation in sacroplasty	Surgical guidelines titled "Surgical Procedure - Long and Short Axis Sacroplasty Techniques with Post-Procedure Positioning and CT Evaluation" were established.

2. Sample size used for the test set and the data provenance

Sample Size: The document refers to "the cadavers included in this study" but does not specify the exact number of cadavers used in the cadaveric study.
Data Provenance: The study was a non-clinical cadaveric study. The country of origin is not specified, but it's a Stryker Instruments submission, likely conducted or overseen in the US.

3. 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 of experts or their qualifications used to establish the ground truth within the cadaveric study itself. However, it does state that the study aimed to demonstrate safety when the procedure "is performed with meticulous imaging guidance by a physician who is trained and experienced in vertebral augmentation and acetabuloplasty." This implies that the study was conducted or observed by such qualified personnel, but they are not explicitly called "experts for ground truth." The "ground truth" here is the direct observation of extravasation or lack thereof in the cadavers.

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

The document does not mention any adjudication method for the cadaveric study. The assessment of extravasation appears to be direct observation or imaging during the study.

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 comparative effectiveness study was not done. This submission is for bone cement, not an AI-powered diagnostic or assistive device.

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

No, a standalone algorithm-only performance study was not done. This is not an AI device. The cadaveric study investigated the physical performance (extravasation) of the bone cement when applied by human operators following specific surgical techniques.

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

For the cadaveric study, the ground truth for "no instances of cement extravasation" was likely established through direct observation and/or post-procedure imaging (e.g., CT evaluation) of the cadaveric specimens, possibly with expert interpretation of these observations/images. This is a direct physical assessment rather than an expert consensus on interpreting indirect data.

8. The sample size for the training set

Not applicable. This submission describes a non-AI medical device (bone cement) and does not involve machine learning models with training sets.

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

Not applicable. As above, there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 12, 2015

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

Re: K150582

Trade/Device Name: 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 Dated: May 15, 2015 Received: May 18, 2015

Dear Ms. 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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kristi Ashton

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150582

Device Name Vertaplex® High Viscosity (HV) Radiopaque Bone Cement

Indications for Use (Describe) vertaPlex HV Radiopaque Bone Cement is indicated for the fixation of patholoqical fractures of the vertebral body usinq 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).
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.

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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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510(k) Summary

l. Contact Details

a. 510(k) Owner:	Stryker Instruments4100 E. Milham AvenueKalamazoo, Michigan 49001USAPh: +1-269-323-7700Fax: +1-269-324-5412
b. FDA EstablishmentRegistration Number:	1811755
c. Contact Person:	Kristi AshtonPh: +1-269-389-5929Fax: +1-269-389-5412Kristi.Ashton @ Stryker.com
d. Date Submitted:	June 11, 2015

II. Subject Device Name

Table 5-1-Subject Devices
Name	Stryker® VertaPlex High Viscosity (HV) Radiopaque Bone Cement
Product code	NDN (primary)LOD (secondary)
Class	II
Regulation	21 CFR 888.3027 Polymethylmethacrylate (PMMA) bone cement
Part Names and Numbers	0406-622-000- VertaPlex HVTM (Dual Pack)
	0406-622-015- VertaPlex HVTM (Single Pack)

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Image /page/4/Picture/1 description: The image shows the Stryker Instruments logo. The word "stryker" is in bold, black, sans-serif font, with a registered trademark symbol next to it. Below the word "stryker" is a horizontal line, and below that is the word "Instruments" in a smaller, bold, black, sans-serif font.

III. Legally Marketed Predicate Device (s)

Predicate Devices
Table 5-2- Predicate Device
Name	Stryker® VertaPlex HV Radiopaque Bone Cement
510(k) Number	K091606
Product Code(s)	NDN (primary)LOD (secondary)
Regulation	21 CFR 888.3027 (Polymethylmethacrylate (PMMA) bone cement
Class	II
Part Names and Numbers	0406-622-000- VertaPlex HVTM (Dual Pack)0406-622-015- VertaPlex HVTM (Single Pack)

dicate Devices

Tables 5-1 and 5-2 identify and describe the predicate device that is currently in commercial distribution, and the subject device of this premarket notification.

IV. Device Description

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V. Indications for use

VertaPlex HV Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

VI. Substantial Equivalence Comparison

Stryker® VertaPlex HV Radiopaque Bone Cement is substantially equivalent to the predicate Stryker® VertaPlex HV Radiopaque Bone Cement (K091606). Stryker® VertaPlex HV Radiopaque Bone Cement has an equivalent intended use, mechanism for use, and mode of action as compared to the predicate device. There have been no changes to the device's fundamental scientific technology or intended use, and yielded no increased risk to safety or effectiveness.

Feature	VertaPlex HV(Subject)	VertaPlex HV(Predicate)K091606	Explanation ofDifferences
Classification	Class II	Class II	Identical
Primary ProductCode	NDN	NDN	Identical
PrimaryRegulation	888.3027(Cement,Bone,Vertebroplasty)	888.3027(Cement,Bone,Vertebroplasty)	Identical
SecondaryProduct Code	LOD	LOD	Identical
Regulation	888.3027(Bone Cement)	888.3027 (BoneCement)	Identical
Regulationdescription	Polymethylmethacrylate(PMMA) bone cement	Polymethylmethacrylate(PMMA) bone cement	Identical
RegulationMedicalSpecialty	Orthopedic	Orthopedic	Identical

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Instruments

Feature	VertaPlex HV(Subject)	VertaPlex HV(Predicate)K091606	Explanation ofDifferences
Indications forUse	VertaPlexHVRadiopaque BoneCement is indicated forthe fixation ofpathological fractures ofthe vertebral body usingvertebroplasty orkyphoplasty. It is alsoindicated for the fixationof pathological fracturesof the sacral vertebralbody or ala using sacralvertebroplasty orsacroplasty. Painfulvertebral compressionfractures may resultfrom osteoporosis,benign lesions(hemangioma), andmalignant lesions(metastatic cancers,myeloma).	VertaPlex HVRadiopaque BoneCement both areindicated for the fixationof pathological fracturesof the vertebral bodyusing vertebroplasty orkyphoplastyprocedures. Painfulvertebral compressionfractures may resultfrom osteoporosis,benign lesions(hemangioma), andmalignant lesions(metastatic cancers,myeloma).	Expanded indicationto include vertebralbody and sacrumand use in sacralvertebroplasty orsacroplasty.
Anatomical Sites	Vertebral body andsacrum	Vertebral body	Addition ofIndications for Useto include thevertebral body andsacrum

VII. Non-Clinical

A cadaveric study in support of the expanded indication was completed. entitled: A Study of Extravasation of Stryker® VertaPlex® HV Radiopaque Bone Cement Comparing the Meticulous Intraoperative Long Axis Versus Short Axis Techniques for Sacroplasty in Osteoporotic Cadavers. This cadaveric study was conducted to provide data and guidelines as to the most conservative approach

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for sacroplasty procedures, to mitigate the risk for extravasation in sacroplasty procedures.

No instances of cement extravasation after administration of VertaPlex HV Radiopaque Bone Cement were observed in the cadavers included in this study, using the long-axis technique or the short-axis technique. The results of this cadaveric study demonstrate no difference in the occurrence of cement extravasation after administration of VertaPlex HV Radiopaque Cement between the long- and short-axis techniques when the sacroplasty procedure is performed with meticulous imaging quidance by a physician who is trained and experienced in vertebral augmentation and acetabuloplasty and when careful post-procedural positioning is used.

Risk of extravasation specific to the new expanded anatomical area can be mitigated with the use of the guidance developed through completion of the cadaveric study which established surgical guidelines. These surgical guidelines, established by Stryker, are titled "Surgical Procedure - Long and Short Axis Sacroplasty Techniques with Post-Procedure Positioning and CT Evaluation."

VIII. Substantial Equivalence Conclusion

There have been no changes to the device since the previous clearance. Minor modifications to the packaging had no impact on the device's fundamental scientific technology or intended use, and yielded no increased risk to safety or effectiveness.

The additional Indications for Use to include the vertebral body and sacrum and sacroplasty procedures are supported by the clinical literature and the cadaveric study report. The cadaveric study vielded information to help mitigate the risk of extravasation with the use of the guidance established by Stryker titled "Surgical Procedure - Long and Short Axis Sacroplasty Techniques with Post-Procedure Positioning and CT Evaluation." In addition, the extensive literature review reveals the safety and efficacy of PMMA when used in the vertebral body and sacrum and in sacral vertebroplasty or sacroplasty procedures.

The information submitted herein supports the substantial equivalence of Stryker® Verteplex® HV Radiopaque Bone Cement for use in the vertebral body and sacrum and in sacral vertebroplasty or sacroplasty procedures.

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.”