(50 days)
No
The device description focuses on the chemical composition and physical properties of a bone cement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the treatment of pathological fractures of the vertebral body, which is a therapeutic purpose. It stabilizes vertebral lesions and compression fractures, providing a direct medical benefit to the patient.
No
The device description indicates it is an injectable bone cement used to stabilize vertebral lesions and compression fractures, not to diagnose a condition.
No
The device description clearly states it is a two-component system consisting of a powder and a liquid, which are physical components, not software.
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 treatment of pathological fractures of the vertebral body using a surgical procedure (vertebroplasty or balloon kyphoplasty). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a bone cement that is injected into the vertebral body to stabilize fractures. This is a material implanted or used within the body for structural support.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, BonOs® Inject bone cement is a medical device used for surgical treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.
Product codes
LOD, NDN
Device Description
BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component system consisting of a powder and a liquid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body
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)
The effectiveness and substantial equivalence of BonOs® Inject was determined by physical, chemical and mechanical comparative tests to OSTEOPAL®V and by comparing the results of the relevant data. In summary, BonOs® Inject is safe and effective for the declared indications and substantially equivalent to OSTEOPAL®V.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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5. 510(k) summary
Preparation date: | February 13, 2009 | |
---|---|---|
Submitter: | aap Biomaterials GmbH | |
Lagerstraße 11-15 | ||
64807 Dieburg | ||
Germany | ||
Phone: +49 6071 / 929-0 | ||
Fax: +49 6071 / 929-100 | APR 1 4 2009 | |
Contact person: | Volker Stirnal | |
Trade name: | BonOs® Inject | |
Common name: | PMMA Bone Cement (For Vertebroplasty) | |
Classification: | Polymethylmethacrylate (PMMA) Bone Cement | |
21 CFR 888.3027, Class II | ||
Product Code: | LOD, NDN | |
Panel: | Orthopedics |
Predicate device to which substantial equivalence is claimed:
Manufacturer | Device Name | 510(k) # |
---|---|---|
Heraeus Kulzer GmbH | OSTEOPAL® V | (K050085) |
Device description:
BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component system consisting of a powder and a liquid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.
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Scientific concepts, significant physical and performance characteristics:
Bone cements in general are self-polymerizing two-component systems comprising a powder and a liguid which polymerize at room temperature immediately after they are mixed together.
The bone cement powder mainly consists of polymethylmethacrylate (PMMA), benzoyl peroxide (BPO) as initiator and zirconium dioxide as radiopacifier. The liquid component comprises monomer methylmethacrylate (MMA) and N,Ndimethyl-p-toluidine (DmpT) as activator. Additionally MMA is stabilized with hydroquinone (HQ).
When the two components are mixed together, the activator DmpT contained in the liquid activates the initiator BPO. This reaction starts polymerization of the monomer MMA, which cross-links with the polymer powder during the ongoing polymerization. As a result, a viscous injectable mass is obtained which can be introduced into the vertebral fracture using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermic reaction respectively. The setting or curing time is greatly influenced by the temperature of the components and environment.
Statement of the intended use:
BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.
Summary of technological characteristics of the new device in comparison to the predicate device:
BonOs® Inject comprises the same chemical components as the legally marketed device OSTEOPAL®V. BonOs® Inject has been and is down to the present day successfully marketed in Europe.
The effectiveness and substantial equivalence of BonOs® Inject was determined by physical, chemical and mechanical comparative tests to OSTEOPAL®V and by comparing the results of the relevant data.
In summary, BonOs® Inject is safe and effective for the declared indications and substantially equivalent to OSTEOPAL®V.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
aap Biomaterials GmbH % Mr. Volker Stirnal Director QA/RA Lagerstrasse 11-15 D 64807 Dieburg Germany
APR 1 4 2009
Re: K090460 Trade/Device Name: BonOs® Inject Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: February 13, 2009 Received: February 23, 2009
Dear Mr. Stirnal:
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 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Volker Stirnal
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Arbarmeinn
Mark N. Melkers Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use
510(k) Number:
Device Name:
BonOs® Inject
Indications for Use:
BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Soulaue Buetip
Concurrence of CDRH, Office of Device
Divi General, Restorative. sion of and Neurological Devices
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