DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT

K061144 · DePuy Orthopaedics, Inc. · MBB · Jun 8, 2006 · Orthopedic

Device Facts

• Record ID: K061144
• Device Name: DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: MBB · Orthopedic
• Decision Date: Jun 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin Bone Cement are both 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

Self-curing polymethylmethacrylate (PMMA) bone cements containing gentamicin antibiotic (1g per 40g powder). Used by orthopedic surgeons in clinical settings to seat and secure metal or plastic prostheses to living bone during the second stage of two-stage revision total joint arthroplasty. CMW 2 and CMW 3 variants offer modified component ratios to provide different setting characteristics for specific surgical needs. The cement acts as a mechanical fixation agent while providing local antibiotic delivery to the surgical site.

Clinical Evidence

Bench testing only. Substantial equivalence is supported by comparative product testing data evaluating setting characteristics and performance against predicate devices.

Technological Characteristics

Self-curing PMMA bone cement; contains 1g gentamicin per 40g PMMA powder. Materials and sterilization methods are consistent with predicate devices. Mechanical fixation principle.

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 CMW 1 Gentamicin Bone Cement (K053002)
• SmartSet GMV Endurance Gentamicin Bone Cement (K041656)
• SmartSet GHV Gentamicin Bone Cement (K033563)
• DePuy CMW 2 Bone Cement (K053003)
• DePuy CMW 3 Bone Cement (K053003)

Submission Summary (Full Text)

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## JUN - 8 2006

## SECTION 5: SECTION 5:

| Trade Name: | DePuy CMW 2 Gentamicin Bone Cement<br>DePuy CMW 3 Gentamicin Bone Cement |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Antibiotic bone cement |
| Classification Name: | Bone cement, antibiotic (21 CFR 888.3027, Product Code MBB) |
| Contact Person: | Natalie S. Heck<br>Manager, Regulatory Affairs<br>DePuy Orthopaedics Inc. |
| | Tel.: [phone]<br>Fax: [phone] |
| Equivalent to: | DePuy CMW 1 Gentamicin Bone Cement (K053002) |
| | SmartSet GMV Endurance Gentamicin Bone Cement (K041656). |
| | SmartSet GHV Gentamicin Bone Cement (K033563). |
| | DePuy CMW 2 Bone Cement (K053003) |
| | DePuy CMW 3 Bone Cement (K053003) |
| Device Description: | DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin<br>Bone Cement are self-curing, polymethylmethacrylate (PMMA) bone<br>cements containing the antibiotic gentamicin (at the rate of 1g active<br>gentamicin in 40g of PMMA bone cement powder), for seating and securing<br>of a metal or plastic prosthesis to living bone. |
| Intended Use: | DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin<br>Bone Cement are both indicated for use in the second stage of a two-stage<br>revision for total joint arthroplasty after the initial infection has been<br>cleared. |
| Substantial<br>Equivalence: | DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin<br>Bone Cement have the same intended use as DePuy CMW 1 Gentamicin<br>Bone Cement, SmartSet GHV Gentamicin Bone Cement and SmartSet<br>GMV Endurance Gentamicin Bone Cement. |

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DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin Bone Cement are composed of the same materials as DePuy CMW 1 Gentamicin Bone Cement, but the ratios of the individual components have been modified to produce cements with subtly different setting characteristics to meet user needs for differing surgical situations. DePuv CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin Bone Cement are similar in design and performance characteristics to DePuy Gentamicin Bone Cement, SmartSet GMV Endurance CMW 1 Gentamicin Bone Cement, SmartSet GHV Gentamicin Bone Cement, DePuy CMW 2 Bone Cement and DePuy CMW 3 Bone Cement; and similar in sterilization and packaging to DePuy CMW 1 Gentamicin Bone Cement, SmartSet GMV Endurance Gentamicin Bone Cement, DePuy CMW 2 Bone Cement and DePuy CMW 3 Bone Cement. The determination of substantial equivalence of DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin Bone Cement to these bone cements was based on a comparison of device technological characteristics and comparative product testing data.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2006

DePuy Orthopaedics, Inc. c/o Ms. Natalie Heck Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46580

Re: K061144

Trade/Device Name: DePuy CMW 2 Gentamicin Bone Cement, DePuy CMW 3 Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: MBB Dated: April 24, 2006 Received: April 25, 2006

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, 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

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Page 2 -- Ms. Natalie Heck

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. 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,

Herbert Lehman mo

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

Enclosure

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## SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin Bone Cement

Indications for Use:

Use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Helent Penner wo

Division Sign-Off Division of General, Restoral ve and Neurological Devices

Co 61144 510(k) Number.

Prescription Use_ X (Per 21 CFR 801 Subpart D) AND/ OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)