PALACOS LV+G

K050854 · Heraeus Kulzer,GmbH · LOD · Jul 7, 2005 · Orthopedic

Device Facts

• Record ID: K050854
• Device Name: PALACOS LV+G
• Applicant: Heraeus Kulzer,GmbH
• Product Code: LOD · Orthopedic
• Decision Date: Jul 7, 2005
• 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 LV+ G is an acrylic bone cement used in orthopedic surgery. It consists of powder and liquid components 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 clinical settings during revision arthroplasty procedures. The addition of gentamicin is the primary functional distinction from the predicate device.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance similarities to the predicate device.

Technological Characteristics

Polymethylmethacrylate (PMMA) bone cement. Formed via exothermic polymerization of powder and liquid components. Contains gentamicin. Classified as Class II, 21 CFR 888.3027, Product Codes LOD and MBB.

Indications for Use

Indicated for use in 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

• OSTEOPAL (K030903)
• PMA P810020

Submission Summary (Full Text)

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## 510(k)

Palacos LV®+ G

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## 510(k) Summary

K050854

| | Mar 29th, 2005 |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of summary | |
| Device trade name | PALACOS® LV + G |
| Common Name | PMMA Bone Cement |
| Classification name | Bone Cement, 888.3027 |
| Identification of the marketed device to which<br>equivalence is claimed | OSTEOPAL® K030903<br>PMA P810020 1998 |
| Description of the device | Palacos® LV + G is an acrylic bone cement for use<br>in orthopedic surgery. It is formed from powder<br>and liquid by exothermic polymerization. It secures<br>the fixation of the grafted artificial joint improving<br>the transfer of forces at the interface implant -<br>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 | The only difference to Osteopal is the additional<br>gentamicin. The cement performs most similar to<br>Osteopal. |
| Submitted by | Dr. C. Tuchscherer<br>phone: [phone]<br>fax: [phone]<br>christian.tuchscherer @heraeus.com |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUL 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Christian Tuchscherer Heraeus Kulzer GmbH Division Heraeus Medical Phillip Reis-Strasse 8/13 Wehrheim, Germany - D-61273

Re: K050854

Trade/Device Name: Palacos® LV + G Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD and MBB Dated: March 30, 2005 Received: April 7, 2005

Dear Dr. Tuchscherer:

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, iisting 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. Christian Tuchscherer

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 it you attent 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/industry/support/index.html.

Sincerely yours,

Hupt Rhodes

Miriam Provost, Ph.D. Acting 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):

Device Name: PALACOS® LV + G

Indications For Use:

PALACOS® LV + 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)

Styt Rlurlie

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(Division Sign-Off Division of General, Restorative. and Neurological Devices

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