REFOBACIN -PALACOS G

K031673 · Heraeus Kulzer GmbH & Co. KG · LOD · May 25, 2004 · Orthopedic

Device Facts

• Record ID: K031673
• Device Name: REFOBACIN -PALACOS G
• Applicant: Heraeus Kulzer GmbH & Co. KG
• Product Code: LOD · Orthopedic
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Palacos G is an acrylic bone cement used in orthopedic surgery. It consists of a powder and liquid component that undergo exothermic polymerization to form a solid material. The device is used to secure the fixation of grafted artificial joints, facilitating the transfer of forces at the implant-bone interface. It is intended for use by surgeons in a clinical setting during the second stage of a two-stage revision procedure for total joint arthroplasty after an initial infection has been resolved. The cement provides mechanical stability for the prosthetic implant, which benefits the patient by restoring joint function and structural integrity.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and established history of use.

Technological Characteristics

Acrylic bone cement (polymethylmethacrylate/PMMA). Formed via exothermic polymerization of powder and liquid components. Class II device (21 CFR 888.3027).

Indications for Use

Indicated for patients undergoing the second stage of a two-stage revision for total joint arthroplasty following the clearance of an initial infection.

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 (P810020)

Reference Devices

• Refobacin®-Palacos® R

Submission Summary (Full Text)

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K031673 page: 1/

510(k)

2nd supplement shipment:changes of May 2004

Palacos® G

MAY 2 5 2004

510(k) Summary

| Applicant's name and address | Heraeus Kulzer GmbH & Co. KG<br>Grüner Weg 11<br>D-63450 Hanau |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact persons | Dr. K.-D. Kühn<br>phone: [phone]<br>fax: [phone]<br>[e-mail] |
| | Dr. C. Tuchscherer<br>phone: [phone]<br>fax: [phone]<br>[e-mail] |
| Date of actualized summary | May 11th, 2004 |
| Device trade name | PALACOS® G |
| Classification name | Bone Cement |
| Identification of the marketed device to which<br>equivalence is claimed | PALACOS® R BONE CEMENT<br>PMA Number: P810020 |
| Description of the device | Palacos® G is an acrylic bone cement for use in<br>orthopedic surgery. It is formed from powder and<br>liquid by exothermic polymerization. It secures the<br>fixation of the grafted artificial joint improving the<br>transfer of forces at the interface implant - bone. |
| Intended use | The cement is indicated for use in the second stage<br>of a two stage revision for total joint arthroplasty<br>after the initial infection has been cleared. |
| Comparison of technological characteristics | This is the well known Refobacin®-Palacos® R<br>being marketed for many years in Europe. It<br>performs most similar to Palacos R. |

Heraeus Kulzer GmbII & Co. KG, KULZER:, Bereich Mcdizin, Dr. Klaus-Dieter Kühn

Image /page/0/Picture/7 description: The image shows a logo with the words "Hercus Krutz" stacked on top of each other. The text is in a bold, sans-serif font. The logo appears to be for a company or organization. The background is a solid color, which contrasts with the text.

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Image /page/1/Picture/1 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 symbol that resembles an abstract human figure with three horizontal lines representing arms or wings.

Public Health Service

MAY 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Klaus-Dieter Kühn Heraeus Kulzer GmbH & Co. KG Grüner Weg 11 D-63450 Hanau Germany

Re: K031673 Trade/Device Name: Palacos G Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD and MBB Dated: February 24, 2004 Received: February 27, 2004

Dear Dr. Kühn:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 adviscd that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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); 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.

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Page 2 - Dr. Klaus-Dieter Kühn

This letter will allow you to begin marketing your device as described in your Section 510(k) I has letter will and w your to be finding of substantial equivalence of your device to a legally promatics notification. The a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Oiner general Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark N. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K031673

Device Name: PALACOS G

Indications For Use:

PALACOS G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

Prescription Use yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use no (21 CFR 807 Subpart C)

(Please do not write BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milkersen

al. Restorative, and Neurological Devices

10(k) Number KO 31673

510(k) Number.

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