(95 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical performance of a bone cement, with no mention of AI or ML technologies.
Yes
The device is a bone cement used for the fixation of pathological fractures of the vertebral body and sacrum, which is a therapeutic intervention aimed at treating painful vertebral compression fractures.
No
The device is a bone cement used for fixing pathological fractures, not for diagnosing medical conditions. It is a therapeutic device.
No
The device description clearly states it is comprised of physical components (liquid and powder) that polymerize to form a hardened acrylic polymer, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of pathological fractures of the vertebral body and sacrum using surgical procedures (vertebroplasty, kyphoplasty, sacroplasty). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a bone cement that is mixed and injected into the body to provide structural support. It is a material used in a surgical procedure.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples from the body.
Therefore, VertaPlex HV Radiopaque Bone Cement is a therapeutic medical device used in surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
NDN, LOD
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebral body and sacrum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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
1
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
2
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.
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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Image /page/3/Picture/1 description: The image shows the logo for Stryker Instruments. The word "stryker" is in a bold, sans-serif font, with a registered trademark symbol to the right of the "r". Below a horizontal line is the word "Instruments" in a smaller, sans-serif font.
510(k) Summary
l. Contact Details
| a. 510(k) Owner: | Stryker Instruments
4100 E. Milham Avenue
Kalamazoo, Michigan 49001
USA
Ph: +1-269-323-7700
Fax: +1-269-324-5412 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| b. FDA Establishment
Registration Number: | 1811755 |
| c. Contact Person: | Kristi Ashton
Ph: +1-269-389-5929
Fax: +1-269-389-5412
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) |
| 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) |
4
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
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
5
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
(Subject) | VertaPlex HV
(Predicate)
K091606 | Explanation of
Differences |
|------------------------------------|----------------------------------------------|----------------------------------------------|-------------------------------|
| Classification | Class II | Class II | Identical |
| Primary Product
Code | NDN | NDN | Identical |
| Primary
Regulation | 888.3027
(Cement,Bone,
Vertebroplasty) | 888.3027
(Cement,Bone,
Vertebroplasty) | Identical |
| Secondary
Product Code | LOD | LOD | Identical |
| Regulation | 888.3027
(Bone Cement) | 888.3027 (Bone
Cement) | Identical |
| Regulation
description | Polymethylmethacrylate
(PMMA) bone cement | Polymethylmethacrylate
(PMMA) bone cement | Identical |
| Regulation
Medical
Specialty | Orthopedic | Orthopedic | Identical |
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Image /page/6/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a registered trademark symbol to the right of the "r". A horizontal line is underneath the word.
Instruments
| Feature | VertaPlex HV
(Subject) | VertaPlex HV
(Predicate)
K091606 | Explanation of
Differences |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | VertaPlexHV
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). | VertaPlex HV
Radiopaque Bone
Cement both are
indicated for the fixation
of pathological fractures
of the vertebral body
using vertebroplasty or
kyphoplasty
procedures. Painful
vertebral compression
fractures may result
from osteoporosis,
benign lesions
(hemangioma), and
malignant lesions
(metastatic cancers,
myeloma). | Expanded indication
to include vertebral
body and sacrum
and use in sacral
vertebroplasty or
sacroplasty. |
| Anatomical Sites | Vertebral body and
sacrum | Vertebral body | Addition of
Indications for Use
to include the
vertebral body and
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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Image /page/7/Picture/1 description: The image shows the logo for Stryker Instruments. The word "stryker" is in bold, black, sans-serif font, with a registered trademark symbol to the right of the "r". Below the word "stryker" is a horizontal line, and below that is the word "Instruments" in a smaller, bold, black, sans-serif font.
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.