DEPUY 1 GENTAMICIN BONE CEMENT

K023103 · DePuy Orthopaedics, Inc. · LOD · Sep 29, 2003 · Orthopedic

Device Facts

• Record ID: K023103
• Device Name: DEPUY 1 GENTAMICIN BONE CEMENT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: Sep 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DePuy 1 Gentamicin 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 1 Gentamicin Bone Cement is a self-curing polymethyl methacrylate (PMMA) bone cement containing one gram of Gentamicin per 40 grams of cement. It is used by orthopedic surgeons during total joint arthroplasty procedures to seat and secure metal or plastic prostheses to living bone. The addition of the antibiotic Gentamicin is intended to provide local delivery of the drug in the context of a two-stage revision surgery after an initial infection has been cleared. The device is prepared and applied by the surgeon in the operating room environment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Self-curing PMMA bone cement; contains 1g Gentamicin per 40g PMMA. Material properties and performance conform to voluntary standards for bone cement.

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 Bone Cement
• BACTISEAL Catheter (Codman)
• OrthoGuard AB Antimicrobial Sleeve (Smith and Nephew)

Submission Summary (Full Text)

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K023103 page 1/2

## 510(k) Summary

DePuy 1 Gentamicin Bone Cement

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

### A. Contact Person:

Cheryl K Hastings Director, Regulatory Affairs [phone] FAX [phone]

### B. Device Information:

| Proprietary Name: | DePuy 1 Gentamicin Bone Cement |
|----------------------------------------------|------------------------------------------------------------------|
| Common Name: | Polymethyl methacrylate (PMMA) bone cement<br>with Antibiotic |
| Regulatory Class and<br>Classification Name: | Class III; no classification name has been<br>established by FDA |
| Product Code: | MBB |

### C. Indications for Use:

DePuy 1 Gentamicin is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

### D. Device Description:

DePuy 1 Gentamicin Bone Cement is a self curing cement, to which one gram of Gentamicin is added in 40 grams PMMA (Polymethyl methacrylate) cement for allowing the seating and securing of a metal or plastic prosthesis to living bone.

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K023103 page \$\frac{2}{2}\$

## E. Substantial Equivalence:

The substantial equivalence of the DePuy 1 Gentamicin Bone Cement is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to DePuy 1 Bone Cement, the BACTISEAL Catheter (Codman) and OrthoGuard AB Antimicrobial Sleeve (Smith and Nephew).

The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance with voluntary performance standards.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol consists of three curved lines that converge and then diverge, creating a sense of movement and dynamism.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 2 9 2003

Ms. Cheryl K. Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

Re: K023103

Trade/Device Name: DePuy 1 Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: June 30, 2003 Received: July 1, 2003

Dear Ms. Hastings:

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- Ms. Cheryl K. Hastings

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 may be obtained 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 A. Millham

Celia 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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K023/03

510(k) Number (if known) Device Name

DePuy 1 Gentamicin Bone Cement

# Indications for Use

DePuy 1 Gentamicin is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark n Millman
(Division Sign-Off)

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

510(k) Number K023103

Prescription Use > > (Per 21 CFR §801 109)

OR

Over-the-Counter Use No

(Optional Format 1-2-96)