MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT

K041656 · DePuy Orthopaedics, Inc. · LOD · Jul 1, 2004 · Orthopedic

Device Facts

• Record ID: K041656
• Device Name: MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements are 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 bone cements containing 1g Gentamicin per 40g PMMA (polymethyl methacrylate and styrene co-polymer). Used by surgeons to seat and secure metal or plastic prostheses to living bone during the second stage of two-stage revision total joint arthroplasty. Cements function via polymerization to fix implants in place while providing local antibiotic delivery. The device is a modification of previously cleared cements, specifically changing the Gentamicin Sulphate ingredient from micronised to non-micronised particles.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and manufacturing similarities to predicate devices.

Technological Characteristics

Self-curing PMMA (polymethyl methacrylate) and styrene co-polymer bone cement; contains 1g Gentamicin Sulphate per 40g cement; non-micronised antibiotic particles; manual mixing/application.

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 (K023103)
• SmartSet GMV Endurance Gentamicin Bone Cement (K033382)
• SmartSet GHV Gentamicin Bone Cement (K033563)

Submission Summary (Full Text)

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

# JUL 01 2004

Image /page/0/Picture/1 description: The image contains the text "Koy1i656" at the top. Below the text is a logo that includes a solid black circle followed by the word "DePuy" in a stylized font. Underneath the logo, there is some additional text that is difficult to read due to its small size and image quality. The overall image appears to be a scan or photograph of a document or label.

## SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>P.O. Box 988<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) CONTACT: | Tiffani Rogers<br>Regulatory Affairs Associate | |
| TRADE NAME: | DePuy 1 Gentamicin Bone Cement<br>SmartSet GMV Endurance Gentamicin Bone Cement. | |
| COMMON NAME: | Polymethyl Methacrylate (PMMA) bone cement with<br>Antibiotic.<br>Polymethyl Methacrylate (PMMA) and styrene co-polymer<br>bone cement with Antibiotic. | |
| CLASSIFICATION: | Class II; 21 CFR 888.3027 | |
| DEVICE PRODUCT CODE: | LOD | |
| SUBSTANTIALLY EQUIVALENT DEVICE: | DePuy 1 Gentamicin Bone Cement (K023103), SmartSet GMV<br>Endurance Gentamicin Bone Cement (K033382) and SmartSet<br>GHV Gentamicin Bone Cement (K033563) | |

#### DEVICE DESCRIPTION:

DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements are self-curing coments, containing one gram of Gentamicin in 40 grams PMMA (Polymethyl methacrylate, and Polymethy) methacrylate and styrene co-polymer). The cements allow the seating and securing of a metal or plastic prosthesis to living bone.

#### INTENDED USE AND INDICATIONS:

DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements are 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:

The DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements have the same basic design and the same intended use as the originally cleared bone cements. The Gentamicin Sulphate used in the cements is to be changed from micronised particles to non-micronised particles. Based on similarities in design, material, manufacturing method and intended use, DePuy believes that the DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin manufactured with non-micronised are substantially equivalent to the previously cleared antibiotic bone cements manufactured with micronised Gentamicin. Lek Pharmaceutical and Chemical Company d.d are to remain the supplier of the active ingredient Gentamicin Sulphate.

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

Image /page/1/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 image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tiffani Rogers DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581- 0988

JUL 01 2004

Re: K041656

Trade/Device Name: DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD, MBB Dated: June 17, 2004 Received: June 18, 2004

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.

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

## Page 2 - Tiffani Rogers

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/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known): Device Name: DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements

Indications for Use;

DePuy 1 Gentamicin Bone Cement and SmartSet GMV Endurance Gentamicin Bone Cement are 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 X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page | of | (Posted November 13, 2003)

Muriam C. Provost

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

Ko41656 510(k) Number_