PALAMED G

K050855 · Heraeus Kulzer,GmbH · LOD · Jul 7, 2005 · Orthopedic

Device Facts

• Record ID: K050855
• Device Name: PALAMED 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

PALAMED® G is an acrylic bone cement used in orthopedic surgery; composed of powder and liquid components that undergo exothermic polymerization. Device secures fixation of grafted artificial joints; improves force transfer at the implant-bone interface. Used in clinical settings by orthopedic surgeons during the second stage of two-stage revision arthroplasty after infection clearance. Contains gentamicin sulphate; features lower initial viscosity compared to predicate. Benefits patient by providing stable fixation of prosthetic components in revision procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance comparison to predicate.

Technological Characteristics

Acrylic bone cement; PMMA-based. Exothermic polymerization process. Contains gentamicin sulphate. Lower initial viscosity compared to predicate. Class II device.

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

• PALACOS® R BONE CEMENT (P810020)

Reference Devices

• PALAMED (K030904)

Submission Summary (Full Text)

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ついい(K)

Palamed® G

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510(k) Summary

| Date of summary | Mar 29th, 2005 |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device trade name | PALAMED® G |
| Common Name | PMMA Bone Cement |
| Classification name | Bone Cement, 888.3027 |
| Identification of the marketed device to which equivalence is claimed | PALACOS® R BONE CEMENT<br>PMA Number: P810020 |
| Description of the device | PALAMED® G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. |
| 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. |
| Comparison of technological characteristics | Palamed® G is similar to Palacos R except for the additional gentamicin sulphate and a lower initial viscosity. Palamed® G performs very similar to Palacos R.<br>See also K030904 (PALAMED). |
| Submitted by | Dr. C. Tuchscherer<br>phone: [phone]<br>fax: [phone]<br>[e-mail] |
| Signature | Image: Signature<br>Date |

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CC02

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 7 - 2005

Dr. Christian Tuchscherer Heraeus Kulzer GmbH Grüner Weg 11 Germany - D-63450 Hanau

Re: K050855 Trade/Device Name: Palamed® G Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD and MBB Dated: March 29, 2005 Received: April 4, 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, 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. Tuchscherer

This letter will allow you to begin marketing your device as described in your Section 510(k) 1 mo letter will and the FDA finding of substantial equivalence of your device to a legally p whather 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/industry/support/index.html.

Sincerely yours,

Hipt Rluder

iriam 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: PALAMED® G

Indications For Use:

PALAMED® 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)

Stypa Plurdin

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

KOSO855 510(k) Number_