OSTEOPAL

K030903 · Heraeus Kulzer GmbH & Co. KG · LOD · Sep 23, 2003 · Orthopedic

Device Facts

• Record ID: K030903
• Device Name: OSTEOPAL
• Applicant: Heraeus Kulzer GmbH & Co. KG
• Product Code: LOD · Orthopedic
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Osteopal® is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixatio of polymer or metallic prosthetic implants to living bone.

Device Story

Osteopal® 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 cement. The device is used by surgeons to secure the fixation of grafted artificial joint implants (hip, knee, or other joints) to living bone, improving force transfer at the implant-bone interface.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device being identical to a previously approved predicate.

Technological Characteristics

Acrylic bone cement composed of powder and liquid components. Polymerization is exothermic. Used for fixation of polymer or metallic prosthetic implants. Class II device (21 CFR 888.3027, Product Code LOD).

Indications for Use

Indicated for fixation of polymer or metallic prosthetic implants to living bone during arthroplastic procedures of the hip, knee, and other joints.

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

• OSTEOPAL® (or Palacos® E-flow) (PMA P810020)

Submission Summary (Full Text)

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ふいいにているほどになるという

Osteopal®

SEP 2 3 2003

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## 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]<br><br>Dr. C. Tuchscherer<br>phone: [phone]<br>fax: [phone]<br>[e-mail] |
| Date of summary | March 19th, 2003 |
| Device trade name | OSTEOPAL® |
| Classification name | Bone Cement |
| Identification of the marketed device Osteopal® to<br>which equivalence is claimed | OSTEOPAL® (or Palacos® E-flow, respectively)<br>PMA (Merck and S.-P.) P810020 1998 |
| Description of the device | Osteopal® 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 | Fixation of prostheses in the bone (partial or total<br>hip joint replacement at the hip, knee or other<br>joints). |
| Comparison of technological characteristics | This is the known Osteopal® marketed by Merck<br>(as Palacos E-Flow marketed by S.-P.,<br>respectively). |

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SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. K. D. Kühn Head of Department Heraeus Kulzer GmbH & Co. KG Grüner Weg 11 Hanau. Germany D-63450

Re: K030903 Trade/Device Name: OSTEOPAL® Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: June 25, 2003 Received: July 14, 2003

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 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); 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. K. D. Kühn

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 from the Division of Small 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. Millman

elia 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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Osteopal®

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## Intended Use

Osteopal® is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixatio of polymer or metallic prosthetic implants to living bone.

Mark A. Melkerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

KO30903

510(k) Number -