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.

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.

AI/ML Overview

This document is a 510(k) summary for the BonOs® HV Genta, BonOs® MV Genta, and BonOs® LV Genta bone cements. It does not describe a study involving an AI/ML powered device, but rather a traditional medical device (bone cement). Therefore, many of the requested fields are not applicable in this context.

Here's the information that can be extracted or noted as not applicable:

1. A table of acceptance criteria and the reported device performance

The document states that 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. It also notes compliance with several ASTM and ISO standards for mechanical and physical properties.

Specific acceptance criteria and reported numerical performance values are not provided in this summary. Instead, the summary generally states that "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."

Acceptance Criteria Category	Specific Standard/Guidance	Reported Device Performance
Sterilization	ISO 11135, ISO 13408-1/2	Verified sterility, validated processes (ethylene oxide, membrane filter sterilization).
Biocompatibility	ISO 10993-1	Conformed to ISO 10993-1, identical materials to well-known bone cements, no additional risks.
Mixing & Application	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Chemical Composition	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Molecular Weight & Polymer Structure	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Physical Properties	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Stability of Components	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Thermal Properties	Special Controls Guidance Document	Comparable to predicate device, in compliance with standards (details not specified).
Mechanical Properties	ASTM F451-16, ISO 5833:2002, ISO 527:1/2, ASTM F2118-14, ASTM D2990-17, ASTM D732-17, ASTM E399-20	Comparable to predicate device, in compliance with these standards (details not specified).
Bacterial Endotoxins	Ph. Eur. 5.01.10 (based on USP <161>), FDA Guidance "Submission and Review of Sterility Information..." (2016)	Test results meet endotoxin limits of 20 EU/device.
Pyrogen Limit	FDA Guidance "Submission and Review of Sterility Information..." (2016)	Device meets pyrogen limit specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document describes a traditional device and its performance testing against standards, not a clinical study with a "test set" in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is not an AI/ML device requiring human expert ground truth for its performance evaluation in that sense. The device's performance is established through laboratory testing against established physical, chemical, and mechanical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as this is not an AI/ML device and does not involve human readers adjudicating findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this traditional medical device, the "ground truth" for performance is based on:

Compliance with recognized international and national standards (ISO, ASTM).
Laboratory test results for physical, chemical, mechanical, and biological properties, compared against pre-defined specifications and/or predicate device performance.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device and therefore does not have a "training set."

9. How the ground truth for the training set was established

This is not applicable as this is not an AI/ML device and therefore does not have a "training set" or corresponding ground truth.

Summary

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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

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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

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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)

K210125

Device Name

BonOs® HV Genta, BonOs® MV Genta, BonOs® LV Genta

Indications for Use (Describe)

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)

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OSARTIS GmbHAuf der Beune 10164839 MünsterGermany	BonOs® HV GentaBonOs® MV GentaBonOs® LV Genta5. 510(k) Summary510(k) Premarket Notification	Date of issue:Mar 10, 2021
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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

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OSARTIS GmbHAuf der Beune 10164839 MünsterGermany	BonOs® HV GentaBonOs® MV GentaBonOs® LV Genta5. 510(k) Summary510(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 CementMBB – Bone Cement, Antibiotics
Panel:	Orthopedic

3. Predicate Device

The predicate devices are as follows:

Rally™ HV AB Bone Cement (510(k) application K143100)
Palacos® R+G (510(k) application K031673)

4. Device Description

5. Indication for Use

Below is the indication for use:

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.

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	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® HVGentaBonOs® MVGentaBonOs® LVGenta	Rally™ HV ABBone CementK143100	Palacos® R+GK031673
Materialpowder	Polymer	Poly(methylacrylate/methylmethacrylate) (PMA/PMMA)	Poly(methylacrylate/methylmethacrylate) (PMA/PMMA)	Poly(methylacrylate/methylmethacrylate) (PMA/PMMA)
	Initiator	Benzoyl peroxide	Benzoyl peroxide	Benzoyl peroxide
	Radio-pacifier	Zirconium dioxide	Barium sulfate	Zirconium dioxide
	ColorAdditives	None	Pigments (FD&CBlue No. 1 andFD&C YellowNo.5)	Chlorophyll VIII
	Antibiotic	Gentamicinsulfate	Gentamicinsulfate	Gentamicinsulfate
MaterialLiquid	Monomer	Methylmethacrylate (MMA)stabilized withHydroquinone	Methylmethacrylate (MMA)stabilized withHydroquinone	Methylmethacrylate (MMA)stabilized withHydroquinone
	Activator	N,N-Dimethyl-p-toluidine	N,N-Dimethyl-p-toluidine	N,N-Dimethyl-p-toluidine
	ColorAdditives	None	None	Chlorophyll VIIIin oil solution
	Powder SterilizationMethod	Ethylene oxide	Gamma-rayirradiation	Ethylene oxide
Method	Liquid SterilizationMethod	Asepticprocessing	Asepticprocessing	Asepticprocessing
	Terminal LiquidSterilization 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.

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OSARTIS GmbHAuf der Beune 10164839 MünsterGermany	BonOs® HV GentaBonOs® MV GentaBonOs® LV Genta5. 510(k) Summary510(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 <161>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).

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OSARTIS GmbHAuf der Beune 10164839 MünsterGermany	BonOs® HV GentaBonOs® MV GentaBonOs® LV Genta5. 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.

Regulation Number and Section

§ 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.”