Vertaplex® High Viscosity (HV) Radiopaque Bone Cement

K150582 · Stryker Corporation · NDN · Jun 12, 2015 · Orthopedic

Device Facts

• Record ID: K150582
• Device Name: Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
• Applicant: Stryker Corporation
• Product Code: NDN · Orthopedic
• Decision Date: Jun 12, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K150582 · Jun 12, 2015	Vertaplex® High Viscosity (HV) Radiopaque Bone Cement	Stryker Corporation	Published clinical literature	The sponsor conducted an extensive literature review to support the safety and efficacy of PMMA bone cement when used in the sacrum and for sacral vertebroplasty/sacroplasty procedures.	Literature review; Sacroplasty; PMMA bone cement; Clinical outcomes

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Extensive literature review of PMMA use in the vertebral body and sacrum; Literature review	Patients undergoing sacral vertebroplasty or sacroplasty	Not applicable for this study	Safety and efficacy of PMMA in sacral procedures

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).

Device Story

VertaPlex HV Radiopaque Bone Cement is a PMMA-based bone cement consisting of a powder component (polymer and barium sulfate) and a liquid monomer component. Components are mixed to initiate polymerization, creating a pourable, injectable material that cures into a hardened acrylic structure. Used by physicians trained in vertebral augmentation and acetabuloplasty to provide long-term load support and bone augmentation for pathological fractures of the vertebral body and sacrum. The device is administered intraoperatively under imaging guidance. The hardened cement stabilizes the fracture site, potentially reducing pain and restoring structural integrity to the affected bone. No software or electronic components are involved.

Clinical Evidence

No clinical trials were performed. Evidence consists of a cadaveric study (n=not specified) comparing long-axis vs. short-axis techniques for sacroplasty to assess cement extravasation. Results showed zero instances of extravasation using either technique when performed with meticulous imaging guidance and post-procedural positioning. Supporting evidence includes an extensive literature review on the safety and efficacy of PMMA in the vertebral body and sacrum.

Technological Characteristics

PMMA bone cement consisting of polymer powder (14g), monomer liquid (9.5ml), and barium sulfate (6g) for radiopacity. Polymerization-based hardening. Sterilization via Ethylene Oxide (EO). No electronic, software, or connectivity components.

Indications for Use

Indicated for fixation of pathological fractures of vertebral body or sacral vertebral body/ala via vertebroplasty, kyphoplasty, or sacroplasty. Patient population includes those with painful vertebral compression fractures due to osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Stryker® VertaPlex HV Radiopaque Bone Cement (K091606)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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*)

| <div> <b> <span style="font-size:14px">✘</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-----------------------------------------------------------------------------------------------------------------|
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

#### l. Contact Details

| a. 510(k) Owner: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, Michigan 49001<br>USA<br>Ph: [phone]<br>Fax: [phone] |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| b. FDA Establishment<br>Registration Number: | 1811755 |
| c. Contact Person: | Kristi Ashton<br>Ph: [phone]<br>Fax: [phone]<br>Kristi.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)<br>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)<br>LOD (secondary) |
| Regulation | 21 CFR 888.3027 (Polymethylmethacrylate (PMMA) bone cement |
| Class | II |
| Part Names and Numbers | 0406-622-000- VertaPlex HVTM (Dual Pack)<br>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

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

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Image /page/5/Picture/1 description: The image shows the logo for Stryker Instruments. The word "stryker" is in bold, black letters with a registered trademark symbol. Below the word "stryker" is a horizontal line, and below that is the word "Instruments" in black, bold letters.

#### 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<br>(Subject) | VertaPlex HV<br>(Predicate)<br>K091606 | Explanation of<br>Differences |
|------------------------------------|----------------------------------------------|----------------------------------------------|-------------------------------|
| Classification | Class II | Class II | Identical |
| Primary Product<br>Code | NDN | NDN | Identical |
| Primary<br>Regulation | 888.3027<br>(Cement,Bone,<br>Vertebroplasty) | 888.3027<br>(Cement,Bone,<br>Vertebroplasty) | Identical |
| Secondary<br>Product Code | LOD | LOD | Identical |
| Regulation | 888.3027<br>(Bone Cement) | 888.3027 (Bone<br>Cement) | Identical |
| Regulation<br>description | Polymethylmethacrylate<br>(PMMA) bone cement | Polymethylmethacrylate<br>(PMMA) bone cement | Identical |
| Regulation<br>Medical<br>Specialty | Orthopedic | Orthopedic | Identical |

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Instruments

| Feature | VertaPlex HV<br>(Subject) | VertaPlex HV<br>(Predicate)<br>K091606 | Explanation of<br>Differences |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | VertaPlexHV<br>Radiopaque Bone<br>Cement is indicated for<br>the fixation of<br>pathological fractures of<br>the vertebral body using<br>vertebroplasty or<br>kyphoplasty. It is also<br>indicated for the fixation<br>of pathological fractures<br>of the sacral vertebral<br>body or ala using sacral<br>vertebroplasty or<br>sacroplasty. Painful<br>vertebral compression<br>fractures may result<br>from osteoporosis,<br>benign lesions<br>(hemangioma), and<br>malignant lesions<br>(metastatic cancers,<br>myeloma). | VertaPlex HV<br>Radiopaque Bone<br>Cement both are<br>indicated for the fixation<br>of pathological fractures<br>of the vertebral body<br>using vertebroplasty or<br>kyphoplasty<br>procedures. Painful<br>vertebral compression<br>fractures may result<br>from osteoporosis,<br>benign lesions<br>(hemangioma), and<br>malignant lesions<br>(metastatic cancers,<br>myeloma). | Expanded indication<br>to include vertebral<br>body and sacrum<br>and use in sacral<br>vertebroplasty or<br>sacroplasty. |
| Anatomical Sites | Vertebral body and<br>sacrum | Vertebral body | Addition of<br>Indications for Use<br>to include the<br>vertebral body and<br>sacrum |

## 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.