SMARTSET GHV GENTAMICIN BONE CEMENT

K033563 · DePuy Orthopaedics, Inc. · LOD · Feb 5, 2004 · Orthopedic

Device Facts

• Record ID: K033563
• Device Name: SMARTSET GHV GENTAMICIN BONE CEMENT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: Feb 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SmartSet GHV 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

SmartSet GHV Gentamicin Bone Cement is a self-curing methyl methacrylate/methyl acrylate copolymer bone cement containing gentamicin antibiotic. It is 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. The device functions by curing in situ to provide mechanical fixation while delivering local antibiotic therapy to the surgical site, potentially reducing the risk of recurrent infection. It is supplied as a powder and liquid component system.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by device description, product testing, and conformance with voluntary performance standards.

Technological Characteristics

Self-curing methyl methacrylate/methyl acrylate copolymer bone cement. Contains gentamicin antibiotic (1g per 40g powder or 0.5g per 20g powder). Material composition, sterilization, and packaging are similar to predicate SmartSet HV 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

• SmartSet HV Bone Cement (K023012)
• DePuy 1 Gentamicin (K023103)
• Simplex P with Tobramycin (K014199)

Submission Summary (Full Text)

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K03 3563

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# 510(k) Summary SmartSet GHV Gentamicin Bone Cement

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

### A. Contact Person:

Tiffani D. Rogers Regulatory Affairs Associate [phone]

### B. Device Information:

| Proprietary Name: | SmartSet GHV Gentamicin<br>Bone Cement |
|----------------------------------------------|------------------------------------------------------------------------------|
| Common Name: | Methyl Methacrylate/Methyl Acrylate Copolymer<br>bone cement with Antibiotic |
| Regulatory Class and<br>Classification Name: | Class II<br>Bone Cement, Antibiotic |
| Product Code: | LOD |

### C. Indications for Use:

SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage rovision for total joint arthroplasty after the initial infection has been cleared.

#### Device Description: D

SmartSet GHV Gentamicin Bone Cement is a self-curing cement, to which one gram of (active) gentamicin is included in 40 grams of bone cement powder and 0.5 gram of (active) gentamicin is included in 20 grams of bone cement powder, for allowing the seating and securing of a metal or plastic prosthesis to living bone.

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## E. Substantial Equivalence:

The substantial equivalence of SmartSet GHV Gentamicin Bone Cement is demonstrated by its similarity in design, materials, sterilization and packaging to SmartSet HV Bone Cement (K023012) and its similarity in indications for use to DePuy 1 Gentamicin (K023103) and Simplex P with Tobramycin (K014199) Bone Cements.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2004

Ms. Tiffani D. Rogers Regulatory Affairs Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581

Rc: K033563

Trade/Device Name: SmartSet GHV Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone ccment Regulatory Class: II Product Code: LOD and MBB Dated: November 10, 2003 Reccived: November 12, 2003

Dear Ms. Rogers:

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. Tiffani D. Rogers

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and wyourse 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,

L. Mark A. Miller

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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# 510(k) Number (if known) Cevice Name

## Indications for Use

1033563

SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a twostage revision for total joint arthroplasty after the initial infection has been clared.

SmartSet GHV Gentamicin Bone Cement

Prescription Use 2 42 (l'er 21 CFR §801.109)

OR

Over-the-Counter Use _ No

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

for Mark A. Millkern

anchi, Restorative ical Devices 33563