DEPUY CMW 1 GENTAMICIN BONE CEMENT

K053002 · DePuy Orthopaedics, Inc. · MBB · Nov 22, 2005 · Orthopedic

Device Facts

• Record ID: K053002
• Device Name: DEPUY CMW 1 GENTAMICIN BONE CEMENT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: MBB · Orthopedic
• Decision Date: Nov 22, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DePuy CMW 1 Gentamicin Bone 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

DePuy CMW 1 Gentamicin Bone Cement is a self-curing PMMA-based bone cement containing gentamicin; used to seat and secure metal or plastic prostheses to living bone during the second stage of two-stage revision total joint arthroplasty. Device is provided in 20g and 40g presentations. Operates via chemical curing process; applied by orthopedic surgeons in clinical/OR settings. Modifications include new 20g presentation and updated liquid component formulation. Output is a hardened cement mantle providing mechanical fixation of implants.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on formulation and manufacturing similarities to predicate devices.

Technological Characteristics

Self-curing Polymethyl Methacrylate (PMMA) bone cement with gentamicin antibiotic. Available in 20g and 40g presentations. Chemical curing mechanism. Class II device per 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

• DePuy 1 Gentamicin Bone Cement (K041656)
• SmartSet GMV Endurance Gentamicin Bone Cement (K033382)
• SmartSet MV Endurance Bone cement (P960001/S1)

Submission Summary (Full Text)

{0}------------------------------------------------

| | NOV 2 2 2005<br>SUMMARY OF SAFETY AND EFFECTIVENESS | K053002 |
|--------------------------------------|-----------------------------------------------------------------------------------------------|---------|
| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>P.O. Box 988<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 | |
| 510(k) CONTACT: | Natalie S. Heck<br>Manager, Regulatory Affairs | |
| TRADE NAME: | DePuy CMW 1 Gentamicin Bone Cement | |
| COMMON NAME: | Polymethyl Methacrylate (PMMA) Bone Cement with<br>Antibiotic. | |
| CLASSIFICATION: | Class II; 21 CFR 888.3027 | |
| DEVICE PRODUCT CODE: | MBB | |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | DePuy 1 Gentamicin Bone Cement (K041656)<br>(now branded DePuy CMW 1 Gentamicin Bone Cement). | |
| | SmartSet GMV Endurance Gentamicin Bone Cement<br>(K033382). | |
| | SmartSet MV Endurance Bone cement (P960001/S1)<br>(previously branded Endurance Bone Cement) | |

## DEVICE DESCRIPTION:

DePuy 1 Gentamicin Bone Cement is a self-curing cement. The cement allows the seating and securing of a metal or plastic prosthesis to living bone. The following modifications are being made:

- . DePuy CMW 1 Gentamicin will be made available in a 20 gram presentation in addition to the previously cleared 40 gram presentation.
- . Changes are being made to the formulation of the bone cement liquid component.

## INTENDED USE AND INDICATIONS:

DePuy CMW 1 Gentamicin Bone 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.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on similarities in formulations, manufacturing methods and intended use, DePuy believes that DePuy CMW 1 Gentamicin Bone Cement is substantially equivalent to the previously cleared and approved bone cements.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

NOV 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Natalie Heck Manager, Regulatory Affairs Depuy Orthopaedics, Inc PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K053002

Trade/Device Name: Depuy CMW 1 Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: MBB Dated: October 24, 2005 Received: October 27, 2005

Dear Ms. Heck:

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.

{2}------------------------------------------------

Page 2 - Natalie Heck

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/industry/support/index.html.

Sincerely yours,

Signature: Mark N. Miller

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications Statement

510(k) Number (if known):

Device Name: DePuy CMW 1 Gentamicin Bone Cement

Indications for Use:

DePuy CMW 1 Gentamicin Bone 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.

Prescription Use (Part 21 CFR 801.Subpart D)

OR/AND

Over-The Counter Use (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)

Page 1 of

5 -

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

1053002 510(k) Number.