Refobacin® Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Description

Refobacin® Bone Cement R is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, produces a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive in the liquid component serves as optical marking of the bone cement at the site of the operation.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Refobacin Bone Cement R" and does not contain information about an AI/ML powered device. As such, I cannot extract information related to acceptance criteria, study plans, or ground truth for an AI-based system.

The document pertains to a medical device in the field of orthopedics, specifically bone cement used in arthroplasty procedures. The submission focuses on demonstrating substantial equivalence to a predicate device (Palacos® G Bone Cement) based on non-clinical testing of mechanical, chemical, physical, and handling characteristics. Clinical data was explicitly not required for this determination of substantial equivalence.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 20, 2015

Biomet Incorporated Carmen Albany, DVM Senior Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581

Re: K150850

Trade/Device Name: Refobacin Bone Cement R Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD, MBB, KIH, JDZ Dated: June 19, 2015 Received: June 22, 2015

Dear Dr. Albany:

This letter corrects our substantially equivalent letter of July 16, 2015.

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

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Page 2 - Carmen Albany, DVM

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.

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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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: January 31, 2017 See PRA Statement below

510(k) Number (if known) K150850

Device Name Refobacin Bone Cement R

Indications for Use (Describe)

Refobacin Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second 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)

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BIOMET

510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Refobacin® Bone Cement R 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact:	Carmen Albany, DVMSr. Regulatory Affairs Specialist, USPhone: 574-371-3024Fax: 574-372-1683
Date:	March 25, 2015
Subject Device:	Trade Name: Refobacin® Bone Cement RClassification Name:• MBB, LOD- Refobacin® Bone Cement R (21 CFR 888.3027)
	Alternative Packaging Configuration Classification Name:• MBB, LOD-Optipac®- Refobacin® Bone Cement R (21 CFR 888.3027)• JDZ- Optipac®- Refobacin® Bone Cement R (21 CFR 888.4210)• KIH- Optipac®- Refobacin® Bone Cement R (21 CFR 888.4200)
	Legally marketed devices to which substantial equivalence is claimed:

PALACOS®G Bone Cement (K031673)* ● *The product obtained for testing and labeling comparison is labeled as Palacos® R+G

Reference Device

. PALACOS®R + G pro (K142157)

Device Description

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BIOMET

510(k) Summarv Refobacin Bone Cement R | Traditional 510(k)

Indications for Use

Refobacin® Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage of a two stage revision for total ioint arthroplasty after the initial infection has been cleared.

Summary of Technological Characteristics

The intended use, indications for use, materials, sterilization methods, cement design, and principle of operation of the subject device are the same as the predicate device. Differences in size offerings, packaging configurations, and shelf life do not introduce any new risks of safety and efficacy. Refobacin® Bone Cement R is substantially equivalent to Palacos® G for the primary intended use of fixation of prosthetic components as described in the device labeling.

Summary of Performance Data (Nonclinical and/or Clinical)

. Non-Clinical Tests
- o Comparative in-vitro testing was performed and the results for Refobacin® Bone Cement R and Optipac® Refobacin® Bone Cement R were compared to that of the predicate, Palacos® G. The results showed that Refobacin® Bone Cement R and Refobacin® Bone Cement R as packaged in the Optipac® possess mechanical, chemical, physical and handling characteristics necessary to fulfill their intended use. Refobacin® Bone Cement R and Optipac® Refobacin® Bone Cement R are substantially equivalent to Palacos® G for their primary intended use of fixation of prosthetic components as described in the device labeling.
Clinical Tests .
- Clinical data was not required to establish substantial equivalence between the o subject Biomet Refobacin® Bone Cement R and the predicate device.

Substantial Equivalence Conclusion

Based on the similarities in design, function, indications for use and fundamental scientific technology, the devices that are the subject of this submission are similar to the predicate devices and do not introduce any new risks of safety or efficacy. Therefore, Biomet concludes that the subject device is substantially equivalent to the predicate device.

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.”