Biomet Bone Cement R

K172408 · Biomet, Inc. · LOD · Oct 5, 2017 · Orthopedic

Device Facts

• Record ID: K172408
• Device Name: Biomet Bone Cement R
• Applicant: Biomet, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: Oct 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Biomet 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.

Device Story

Biomet Bone Cement R is a two-component (powder and liquid) fast-setting acrylic bone cement. Mixing components creates a paste used in orthopedic surgery to anchor prosthetic components to living bone. The cement facilitates stable fixation by transferring mechanical stresses from the prosthesis to the bone. The powder contains zirconium dioxide as an X-ray contrast medium; the liquid contains a chlorophyll additive for optical marking at the surgical site. Used by surgeons in operating rooms during joint arthroplasty procedures. The device provides mechanical stability for prosthetic implants.

Clinical Evidence

No clinical data was required to establish substantial equivalence. Evidence is based on non-clinical comparative in-vitro testing against the predicate, demonstrating equivalent mechanical, chemical, and physical characteristics. Biocompatibility was confirmed via cytotoxicity testing (ISO 10993-5) and Bacterial Endotoxin Testing (BET).

Technological Characteristics

Two-component acrylic (PMMA) bone cement system. Includes zirconium dioxide (radiopaque) and chlorophyll (optical marker). Principle of operation: chemical polymerization upon mixing. Sterilization method not specified. No software or electronic components.

Indications for Use

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.

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 R Bone Cement (K030902)

Submission Summary (Full Text)

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October 5, 2017

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

Re: K172408

Trade/Device Name: Biomet Bone Cement R Regulation Number: 21 CFR 888,3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD Dated: August 7, 2017 Received: August 9, 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 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.

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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/MedicalDevicesforYou/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,

## Vincent J. Devlin -S

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

Enclosure

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| Form Approved: OMB No. 0910-0120 | |
|----------------------------------|--|
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |

| 510(k) Number (if known) | K172408 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Biomet Bone Cement R |
| Indications for Use (Describe) | Biomet 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. |

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | <div style="display:inline-block"><span style="text-decoration:underline">Prescription Use (Part 21 CFR 801 Subpart D)</span></div> |
| | <div style="display:inline-block"><span style="text-decoration:underline">Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> |

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## 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 Biomet® 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 Specialist<br>Telephone: [phone])<br>Fax: [phone]) |
| Date: | October 2, 2017 |
| Subject Device: | Trade Name: Biomet® Bone Cement R (K172408)<br>Common Name: Bone Cement |
| | Classification Name:<br>• LOD-Biomet® Bone Cement R (21 CFR 888.3027) |
| Predicate Device(s): | K030902 PALACOS® R Bone Heraeus Kulzer<br>Cement GmbH & Co. |
| Device Description: | Biomet® Bone Cement R is a fast setting acrylic cement,<br>for use in bone surgery. Mixing of the two component<br>system, consisting of a powder and a liquid, produces a<br>paste, which is used to anchor the prosthesis to the bone.<br>The hardened bone cement allows stable fixation of the<br>prosthesis and transfers stresses produced in a<br>movement to the bone via the large interface. Insoluble<br>zirconium dioxide is included in the cement powder as an<br>X-ray contrast medium. The chlorophyll additive in the<br>liquid component serves as optical marking of the bone<br>cement at the site of the operation. |
| Indications for Use: | Biomet® Bone Cement R is indicated for use as bone<br>cement in arthroplasty procedures of the hip, knee, and<br>other joints to fix plastic and metal prosthetic parts to<br>living bone. |

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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 pack size offerings and shelf life do not introduce any new risks of safety and efficacy. Biomet® Bone Cement R is substantially equivalent to PALACOS® R 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 Biomet® Bone Cement R were compared to that of the predicate, PALACOS® R. The results showed that Biomet® Bone Cement R possesses mechanical, chemical, physical and handling characteristics necessary to fulfill the intended use. Biomet® Bone Cement R is substantially equivalent to PALACOS® R 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.
- Cytotoxicity Testing O
- The biocompatibility evaluation of Biomet® ● Bone Cement R was conducted in accordance with ISO 10993-5. Cytotoxicity tests demonstrated that the acceptance criteria have been met.
- Clinical Tests: ●
- o Clinical data was not required to establish substantial equivalence between the subject Biomet® 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 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.