(59 days)
Not Found
No
The device description explicitly states it is a "traditional bone cement product" and the performance studies focus on material properties and mechanical performance, with no mention of AI/ML or related concepts.
Yes
The device is used to fix prostheses to living bone, directly participating in the reconstruction and functional improvement of a patient's musculoskeletal system. This corrective action, aimed at restoring normal function and mitigating disability, aligns with the definition of a therapeutic device.
No
Explanation: The device is a bone cement used for fixation of prostheses, which is a therapeutic function, not a diagnostic one. It does not measure, analyze, or interpret data to identify a condition or disease.
No
The device description explicitly states it is a PMMA, radiopaque bone cement, which 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 is for the "fixation of prothesis to living bone". This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a bone cement, a material used to physically attach an implant to bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are intended for the fixation of prothesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Product codes (comma separated list FDA assigned to the subject device)
LOD, MBB
Device Description
BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are PMMA, radiopaque bone cements, containing gentamicin, designed for the fixation of prothesis to the living bone. BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are traditional bone cement products. The bone cement is made of two separate sterile components. When both components are mixed together, they become a self-hardening, radiopaque bone cement which fixes the implant and transfer stresses evenly to the bone. The liquid is contained in a vial and the powder in a pouch; these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, singleuse and sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
living bone
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)
This 510(k) notification provided performance data to establish the substantial equivalence of the new bone cements to the predicate bone cement. Performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002.
Sterilization and Shelf Life: The sterilization process, including the ethylene oxide method and the membrane filter sterilization has been validated and the sterility of the subject devices has been verified according to ISO 11135 and ISO 13408-1/2.
Biocompatibility: The biological evaluation of BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta was performed in accordance with ISO 10993-1. BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta contain identical materials as other well-known bone cements on the market and shows no additional risks. Evaluation for BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta additionally conformed to ISO 10993-1.
Performance Testing (Chemical, Material and Mechanical): Performance testing was performed to characterize the bone cements in accordance with special controls quidance document. This testing included the following:
- Mixing and Application characteristics (e.g. dough time, setting time, viscosity, intrusion )
- Chemical Composition (e.g. trace elements, residual low MW molecules, leachables)
- Molecular weight and Polymer structure (e.g. molecular weight, glass transition temperature)
- Physical Properties (e.g. porosity, shrinkage)
- Stability of Components (e.g. change in monomer viscosity due to artificial aging)
- Thermal Properties (e.g. maximum polymerization temperature)
- Mechanical properties (e.g. cyclic fatigue properties, bending properties, compressive properties, tensile properties, fracture toughness)
Results show comparable performances to the predicate device and are in compliance with ASTM F451-16, ISO 5833:2002, ISO 527:1/2, ASTM F2118-14, ASTM D2990-17, ASTM D732-17 and ASTM E399-20.
The performance data demonstrate that the new devices BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are substantially equivalent to the predicate device Rally™ HV AB Bone Cement 510(k) application K143100 and meet the requirements of the Special Controls Guidance document.
Bacterial endotoxins of BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta have been evaluated using Recombinant Factor C Assay (EndoZyme) following Ph. Eur. 5.01.10, based on USP Test results meet the endotoxin limits of 20 endotoxin units (EU)/device as defined in USP and as recommended by the FDA quidance "Submission and Review of Sterlity Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (2016). This Test for bacterial endotoxins is performed for all produced batches. The device meets the pyrogen limit specifications as described by the FDA quidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" (2016).
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
March 19, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized caduceus symbol. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
OSARTIS GmbH Volker Stirnal Director, Quality Assurance and Regulatory Affairs Auf der Beune 101 Münster, 64839 Germany
Re: K210125
Trade/Device Name: BonOs ® HV Genta, BonOs® MV Genta, BonOs® LV Genta Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD, MBB Dated: January 15, 2021 Received: January 19, 2021
Dear Volker 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
BonOs® HV Genta, BonOs® MV Genta, BonOs® LV Genta
Indications for Use (Describe)
BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are intended for the fixation of prothesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
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 comblete 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."
FORM FDA 3881 (6/20)
3
| OSARTIS GmbH
Auf der Beune 101
64839 Münster
Germany | BonOs® HV Genta
BonOs® MV Genta
BonOs® LV Genta
5. 510(k) Summary
510(k) Premarket Notification | Date of issue:
Mar 10, 2021 |
| --------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------- | -------------------------------- |
|---|
5. 510(k) Summary
1. General Information
Submitter and Owner of the 510(k) 1.1
OSARTIS GmbH Auf der Beune 101 64839 Münster Germany Phone: +49 6071 / 929-0 +49 6071 / 929-100 Fax:
1.2 Contact Person
Volker Stirnal
Devices Subject of this 510(k) 1.3
- BonOs® HV Genta
- BonOs® MV Genta
- BonOs® LV Genta
1.4 Date of Preparation
March 10, 2021
2. Name of the Device and Classification Information
This traditional 510(k) has been submitted for the following devices.
- BonOs® HV Genta
- BonOs® MV Genta
- BonOs® LV Genta
2.1 Trade/Proprietary Name
-
BonOs® HV Genta
-
BonOs® MV Genta
-
BonOs® LV Genta
2.2 Common/Usual Name
PMMA bone cement with antibiotic for orthopedics
4
| OSARTIS GmbH
Auf der Beune 101
64839 Münster
Germany | BonOs® HV Genta
BonOs® MV Genta
BonOs® LV Genta
5. 510(k) Summary
510(k) Premarket Notification | Date of issue:
Mar 10, 2021 |
| --------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------- |
|---|
2.3 Classification Information
| Classification Name: | Polymethylmethacrylate (PMMA) Bone Cement |
|---|---|
| Classification Regulation: | 21 CFR § 888.3027 |
| Regulatory Class: | Class II |
| Product Code: | LOD - Bone Cement |
| MBB – Bone Cement, Antibiotics | |
| Panel: | Orthopedic |
3. Predicate Device
The predicate devices are as follows:
4. Device Description
BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are PMMA, radiopaque bone cements, containing gentamicin, designed for the fixation of prothesis to the living bone. BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are traditional bone cement products. The bone cement is made of two separate sterile components. When both components are mixed together, they become a self-hardening, radiopaque bone cement which fixes the implant and transfer stresses evenly to the bone. The liquid is contained in a vial and the powder in a pouch; these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, singleuse and sterile.
5. Indication for Use
Below is the indication for use:
BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are intended for the fixation of prothesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
6. Comparison of the technological Characteristics with the Predicate Device
BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta share many of the same technological characteristics compared to the predicate Rally™ HV AB Bone Cement, including important considerations such as materials, mechanical performance and chemical-physical performances, for this reason, a second predicate (Palacos® R+G) was included.
5
| OSARTIS GmbH
Auf der Beune 101
64839 Münster
| Germany | BonOs® HV Genta | Date of issue: | |
|---|---|---|---|
| BonOs® MV Genta | Mar 10, 2021 | ||
| BonOs® LV Genta | |||
| 5. 510(k) Summary | |||
| 510(k) Premarket Notification |
These comparisons are summarized in Table 2.
| Table 2: Comparison of the Technological Characteristics with the Predicate Devices | ||
|---|---|---|
| Characteristics | BonOs® HV
Genta
BonOs® MV
Genta
BonOs® LV
Genta | Rally™ HV AB
Bone Cement
K143100 | Palacos® R+G
K031673 | |
|--------------------|----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| Material
powder | Polymer | Poly
(methylacrylate/
methylmethacryla
te) (PMA/PMMA) | Poly
(methylacrylate/
methylmethacryla
te) (PMA/PMMA) | Poly
(methylacrylate/
methylmethacryla
te) (PMA/PMMA) |
| | Initiator | Benzoyl peroxide | Benzoyl peroxide | Benzoyl peroxide |
| | Radio-
pacifier | Zirconium dioxide | Barium sulfate | Zirconium dioxide |
| | Color
Additives | None | Pigments (FD&C
Blue No. 1 and
FD&C Yellow
No.5) | Chlorophyll VIII |
| | Antibiotic | Gentamicin
sulfate | Gentamicin
sulfate | Gentamicin
sulfate |
| Material
Liquid | Monomer | Methylmethacryla
te (MMA)
stabilized with
Hydroquinone | Methylmethacryla
te (MMA)
stabilized with
Hydroquinone | Methylmethacryla
te (MMA)
stabilized with
Hydroquinone |
| | Activator | N,N-Dimethyl-p-
toluidine | N,N-Dimethyl-p-
toluidine | N,N-Dimethyl-p-
toluidine |
| | Color
Additives | None | None | Chlorophyll VIII
in oil solution |
| | Powder Sterilization
Method | Ethylene oxide | Gamma-ray
irradiation | Ethylene oxide |
| Method | Liquid Sterilization
Method | Aseptic
processing | Aseptic
processing | Aseptic
processing |
| | Terminal Liquid
Sterilization Method | Ethylene oxide | Ethylene oxide | Ethylene oxide |
7. Performance Data
This 510(k) notification provided performance data to establish the substantial equivalence of the new bone cements to the predicate bone cement. Performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002. The following is a summary of the performance data.
6
| OSARTIS GmbH
Auf der Beune 101
64839 Münster
Germany | BonOs® HV Genta
BonOs® MV Genta
BonOs® LV Genta
5. 510(k) Summary
510(k) Premarket Notification | Date of issue:
Mar 10, 2021 |
| --------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------- | -------------------------------- |
|---|
Sterilization and Shelf Life: The sterilization process, including the ethylene oxide method and the membrane filter sterilization has been validated and the sterility of the subject devices has been verified according to ISO 11135 and ISO 13408-1/2.
Biocompatibility: The biological evaluation of BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta was performed in accordance with ISO 10993-1. BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta contain identical materials as other well-known bone cements on the market and shows no additional risks. Evaluation for BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta additionally conformed to ISO 10993-1.
Performance Testing (Chemical, Material and Mechanical): Performance testing was performed to characterize the bone cements in accordance with special controls quidance document. This testing included the following:
- Mixing and Application characteristics (e.g. dough time, setting time, viscosity, intrusion )
- Chemical Composition (e.g. trace elements, residual low MW molecules, leachables)
- Molecular weight and Polymer structure (e.g. molecular weight, glass transition temperature)
- Physical Properties (e.g. porosity, shrinkage)
- Stability of Components (e.g. change in monomer viscosity due to artificial aging)
- Thermal Properties (e.g. maximum polymerization temperature)
- Mechanical properties (e.g. cvclic fatigue properties, bending properties, compressive properties, tensile properties, fracture toughness)
Results show comparable performances to the predicate device and are in compliance with ASTM F451-16, ISO 5833:2002, ISO 527:1/2, ASTM F2118-14, ASTM D2990-17, ASTM D732-17 and ASTM E399-20.
The performance data demonstrate that the new devices BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are substantially equivalent to the predicate device Rally™ HV AB Bone Cement 510(k) application K143100 and meet the requirements of the Special Controls Guidance document.
Bacterial endotoxins of BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta have been evaluated using Recombinant Factor C Assay (EndoZyme) following Ph. Eur. 5.01.10, based on USP Test results meet the endotoxin limits of 20 endotoxin units (EU)/device as defined in USP and as recommended by the FDA quidance "Submission and Review of Sterlity Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (2016). This Test for bacterial endotoxins is performed for all produced batches. The device meets the pyrogen limit specifications as described by the FDA quidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" (2016).
7
| OSARTIS GmbH
Auf der Beune 101
64839 Münster
Germany | BonOs® HV Genta
BonOs® MV Genta
BonOs® LV Genta
5. 510(k) Summary | Date of issue:
Mar 10, 2021 |
|---------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------|
| 510(k) Premarket Notification | | |
8. Conclusion
BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence of the subject to the predicate devices.