(157 days)
Not Found
No
The description focuses on the material properties and intended use of a bone cement, with no mention of AI or ML.
Yes
The device is a bone cement used to fix prosthetic implants during arthroplasty procedures, which is a therapeutic intervention aimed at treating joint conditions.
No
The device, BonOs R Genta, is a bone cement used for fixing prosthetic implants during arthroplasty procedures, specifically in cases of joint infection. It is a material used in treatment, not for diagnosing a condition.
No
The device description clearly states it is a "fast-setting acrylic resin" and "bone cement," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that BonOs R Genta is for "fixation of polymer or metallic prosthetic implants to living bone" during surgical procedures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a "fast-setting acrylic resin" that acts as a "bone cement" to "fix the implant and transfers stresses evenly to the bone." This describes a material used within the body for structural support, not a test performed on a sample outside the body to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or screening.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. BonOs R Genta is used in vivo (within the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The BonOs R Genta bone cement 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 when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second stage of a two-stage revision after the initial infection has been cleared.
Product codes (comma separated list FDA assigned to the subject device)
LOD, MBB
Device Description
BonOs R Genta is a fast-setting acrylic resin with the addition of gentamicin sulfate for use in bone surgery. The bone cement is made of two separate sterile components. When both cement components are mixed together, they become a self hardening, radiopaque bone cement which fixes the implant and transfers stresses evenly to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, knee and other joints
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)
Equivalence was verified by physical, chemical and mechanical comparative tests to Palacos R+G.
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
| aap Biomaterials GmbH
Lagerstraße 11 – 15
64807 Dieburg
| Germany | BonOs R Genta | 164-0059-02 |
|---|---|---|
| 5. 510(k) Summary | Date of issue: | |
| 07.12.2012 | ||
| 510(k) Premarket Notification PO-35 | page 1 of 3 |
5. 510(k) summary
7 2013 MAR
.
.
ાર
| Preparation date: | 07.12.2012 |
|---|---|
| Submitter: | aap Biomaterials GmbH |
| Lagerstraße 11-15 | |
| 64807 Dieburg | |
| Germany | |
| Phone: +49 6071 / 929-0 | |
| Fax: +49 6071 / 929-100 | |
| Contact person: | Volker Stirnal |
| Trade name: | BonOs R Genta |
| Common name: | PMMA Bone Cement |
| Classification: | Polymethylmethacrylate (PMMA) Bone Cement |
| 21 CFR 888.3027, Class II | |
| Product Code: | LOD, Bone Cement |
| MBB, Bone Cement, Antibiotic | |
| Panel: | Orthopedics |
Predicate device to which substantial equivalence is claimed:
| Manufacturer | Device Name | 510(k) # |
|---|---|---|
| Heraeus | Palacos R+G | (K031673) |
1
| aap Biomaterials GmbH
Lagerstraße 11 – 15
64807 Dieburg
Germany | BonOs R Genta
- 510(k) Summary
510(k) Premarket Notification PO-35 | 164-0059-02
Date of issue:
07.12.2012
page 2 of 3 |
| -------------------------------------------------------------------------- | ------------------------------------------------------------------------------- | -------------------------------------------------------------------- |
|---|
Device description:
BonOs R Genta is a fast-setting acrylic resin with the addition of gentamicin sulfate for use in bone surgery. The bone cement is made of two separate sterile components. When both cement components are mixed together, they become a self hardening, radiopaque bone cement which fixes the implant and transfers stresses evenly to the bone.
Scientific concepts, significant physical and performance characteristics:
Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together.
The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide (as an initiator) is included. The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization.
When the powder and liquid components are mixed together, the activator DmpT, contained in the liquid activates the initiator in the powder component. This reaction starts the polymerization of the MMA, which is bonded with the polymer powder during ongoing polymerization. A description of polymerization technology is depictured in section 10- Executive summary, annex 10 - D.
As a result, a viscous paste is obtained which can be introduced into bone using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermic reaction respectively. After curing, the bone cement is able to fix the implant. The setting or curing time is greatly influenced by the temperature of the components and environment, which is common for all acrylic bone cements.
Statement of the intended use:
The BonOs R Genta bone cement 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 when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second stage of a two-stage revision after the initial infection has been cleared.
2
| aap Biomaterials GmbH
Lagerstraße 11 – 15
64807 Dieburg
Germany | BonOs R Genta
- 510(k) Summary
510(k) Premarket Notification PO-35 | 164-0059-02
Date of issue:
07.12.2012
page 3 of 3 |
| -------------------------------------------------------------------------- | ------------------------------------------------------------------------------- | ---------------------------------------------------------------- |
|---|
3 3
Summary of technological characteristics of the new device in comparison to the predicate devices:
BonOs R Genta bone cement comprises the same materials, mechanical safety and performance as the legally marketed devices Palacos R+G.
| Trade Name | BonOs R Genta | Palacos R+G | |
|---|---|---|---|
| Common name | PMMA Bone | ||
| Cement | PMMA Bone | ||
| Cement | |||
| Responsible | |||
| manufacturer | aap Biomaterials | Heraeus Kulzer | |
| 510(k) Number | - | K031673 | |
| Device Classification | |||
| Name | Cement, Bone | Cement, Bone | |
| Product Code | LOD, MBB | LOD, MBB | |
| Classification | Class II | Class II | |
| Regulation no. | 21 CFR 888.3027 | 21 CFR 888.3027 | |
| Material | |||
| Powder | Polymer | Poly(methyl acrylate, methyl methacrylate) | Poly(methyl acrylate, methyl |
| methacrylate)* | |||
| Initiator | Di-benzoyl | ||
| peroxide | Di-benzoyl | ||
| peroxide | |||
| Radiopacifier | Zirconium dioxide | Zirconium dioxide | |
| Antibiotic | Gentamicin | Gentamicin | |
| Liquid | Monomer | Methylmethacrylate | |
| (stabilized with | |||
| hydroquinone) | Methylmethacrylate | ||
| (stabilized with | |||
| hydroquinone)* | |||
| Activator | N,N-dimethyl-p- | ||
| toluidine | N,N-dimethyl-p- | ||
| toluidine |
- contains Chlorophyll Copper Complex
BonOs R Genta is substantially equivalent to Palacos R Genta (K031673)in regard to intended use, materials and operational principles as a bone cement. Equivalence was verified by physical, chemical and mechanical comparative tests to Palacos R+G.
In summary, BonOs R Genta bone cement is as safe and effective for the declared indications as the predicate devices Palacos R+G.
5 - 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2013
aap Biomaterials GmbH % Mr. Volker Stirnal Director Quality Assurance and Regulatory Affairs Lagerstrasse 11-15 64807 Dieburg Germany
Re: K123081
Trade Name: BonOs R Genta Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD, MBB Dated: January 25, 2013 Received: January 28, 2013
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 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
4
Page 2 - Mr. Volker Stirnal
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Erin DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| aap Biomaterials GmbH |
|---|
| Lagerstraße 11 – 15 |
| 64807 Dieburg |
| Germany |
| BonOs R Genta |
|---|
| 4. Indications for Use Statement |
| 510(k) Premarket Notification PO-35 |
|---|
| ------------------------------------- |
| 164-0058-01 | |
|---|---|
| Date of issue: | 27.09.2012 |
4. Indications for Use
K123081 510(k) Number:
Device Name:
BonOs R Genta
Indications for Use:
BonOs R Genta 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 when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second stage of a two-stage revision after the initial infection has been cleared.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -A
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123081