Refobacin Bone Cement R

K171540 · Biomet, Inc. · LOD · Aug 30, 2017 · Orthopedic

Device Facts

• Record ID: K171540
• Device Name: Refobacin Bone Cement R
• Applicant: Biomet, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: Aug 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 joint arthroplasty after the initial infection has been cleared.

Device Story

Refobacin Bone Cement R is a two-component (powder and liquid) fast-setting acrylic bone cement containing gentamicin; used in orthopedic surgery to anchor prosthetic components to living bone. Powder contains zirconium dioxide as an X-ray contrast medium; liquid contains chlorophyll for optical marking at the surgical site. Mixing components creates a paste; hardens to provide stable fixation and stress transfer between prosthesis and bone. Used by surgeons in clinical settings during revision arthroplasty. Benefits include secure prosthetic fixation in post-infection reconstruction scenarios.

Clinical Evidence

No clinical data required. Substantial equivalence established via comparative in-vitro bench testing against predicate PALACOS® G, confirming mechanical, chemical, physical, and handling characteristics. Bacterial Endotoxin Testing (BET) confirmed pyrogen limit specifications met.

Technological Characteristics

Two-component PMMA bone cement system. Contains gentamicin, zirconium dioxide (radiopaque), and chlorophyll (optical marker). Principle of operation: chemical polymerization of acrylic components to form a load-bearing interface. Sterilization method not specified.

Indications for Use

Indicated for patients undergoing hip, knee, or other joint arthroplasty revision procedures necessitated by prior joint infection; specifically for use in the second stage of a two-stage revision after initial infection clearance.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• PALACOS® G (K031673)

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

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

August 30, 2017

Biomet Inc. Ms. Heidi Busz Regulatory Affairs Associate 56 East Bell Drive Warsaw, Indiana 46581

Re: K171540

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 Dated: July 17, 2017 Received: July 18, 2017

Dear Ms. Busz:

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-

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

{1}------------------------------------------------

related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | K171540<br>Page 1 of 1<br>Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| <b>Indications for Use</b> | | |
| 510(k) Number ( <i>if known</i> ) | K171540 | |
| 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<br>to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous<br>arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage of a two stage revision<br>for total joint arthroplasty after the initial infection has been cleared. | |
| Type of Use (Select one or both, as applicable) | <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> | <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |
| | CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| <p>This section applies only to requirements of the Paperwork Reduction Act of 1995.</p> <p><b>*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*</b></p> <p>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 complete 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:</p> <p>Department of Health and Human Services<br/>Food and Drug Administration<br/>Office of Chief Information Officer<br/>Paperwork Reduction Act (PRA) Staff<br/>[e-mail]</p> <p>"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."</p> | | |
| FORM FDA 3881 (8/14) | | Page 1 of 1<br>PSC Publishing Services [phone]<br>EF |

মেয়ে

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a gray sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.

# 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.<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Establishment Registration Number: 1825034 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Heidi Busz<br>Regulatory Affairs Associate<br>Telephone: [phone])<br>Fax: fax [phone]) |
| Date: | May 23, 2017 |
| Subject Device: | Trade Name: Refobacin Bone Cement R<br>Common Name: Bone Cement |
| | Classification Name:<br>• LOD, MBB – Polymethylmethacrylate (PMMA) bone<br>cement (21 CFR 888.3027) |
| Predicate Device(s): | K031673 PALACOS® G Heraeus Kulzer<br>Bone Cement GmbH & Co.<br>The product obtained for testing and labeling comparison is<br>labeled as PALACOS® R+G. |
| Device<br>Description: | Refobacin® Bone Cement R is a fast setting acrylic<br>cement containing gentamicin, for use in bone surgery.<br>Mixing of the two component system, consisting of a<br>powder and a liquid, produces a paste, which is used to<br>anchor the prosthesis to the bone. The hardened bone<br>cement allows stable fixation of the prosthesis and<br>transfers stresses produced in a movement to the bone<br>via the large interface. Insoluble zirconium dioxide is<br>included in the cement powder as an X-ray contrast<br>medium. The chlorophyll additive in the liquid component<br>serves as optical marking of the bone cement at the site<br>of the operation. |
| Indications for Use: | Refobacin Bone Cement R is indicated for use as bone<br>cement in arthroplasty procedures of the hip, knee, and |

{4}------------------------------------------------

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 subiect device are the same as the predicate device. Differences in size offerings 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:

- Comparative in-vitro testing was performed and the O results for Refobacin® Bone Cement R were compared to that of the predicate, PALACOS® G. The results showed that Refobacin® Bone Cement R possesses mechanical, chemical, physical and handling characteristics necessary to fulfill the intended use. 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. Bacterial Endotoxin Testing (BET) O
- BET demonstrated the pyrogen limit ● specifications have been met.
- Clinical Tests: ●
- Clinical data was not required to establish o substantial equivalence between the subject Refobacin® Bone Cement R and the predicate device.

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

# Substantial Equivalence Conclusion