SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT

K033382 · DePuy Orthopaedics, Inc. · LOD · Feb 5, 2004 · Orthopedic

Device Facts

• Record ID: K033382
• Device Name: SMARTSET GMV ENDURANCE 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 GMV Endurance 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 GMV Endurance Gentamicin Bone Cement is a self-curing PMMA and styrene co-polymer bone cement containing an antibiotic. It is used by orthopedic surgeons during the second stage of two-stage revision total joint arthroplasty to seat and secure metal or plastic prostheses to living bone. The device functions as a mechanical fixation agent, providing structural support for the implant while delivering gentamicin to the surgical site. It is intended for clinical use in hospital or surgical settings.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing and conformance to performance standards.

Technological Characteristics

Self-curing PMMA and styrene co-polymer bone cement containing gentamicin. Material composition, sterilization, and packaging are consistent with predicate devices. Class II device (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 (K023103)
• Simplex P with Tobramycin Bone Cement (K014199)
• Endurance Bone Cement (P960001/S003)

Submission Summary (Full Text)

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

# (033382

FEB - 5 2004

### 510(k) Summary SmartSet GMV Endurance Gentamicin Bone Cement

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

#### A. Contact Person:

Tiffani D. Rogers Regulatory Affairs Associatc [phone]

#### Device Information:

| Proprietary Name: | SmartSet GMV Endurance Gentamicin |
|----------------------------------------------|----------------------------------------------------------------------------------|
| | Bone Cement |
| Common Name: | Polymethylmethacrylate (PMMA) and styrene co-polymer bone cement with Antibiotic |
| Regulatory Class and<br>Classification Name: | Class II; 21 CFR 888.3027 |
| Product Code: | LOD |

#### C. Indications for Use:

SmartSet GMV Endurance 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 clearcd.

#### D. Device Description:

SmartSet GMV Endurance Gentamicin Bone cement is a self-curing cement, containing one seating and securing of seating and securing of a metal or plastic prosthesis to I ving bone. -

#### E. Substantial Equivalence:

The substantial equivalence of the SmartSet GMV Endurance Bone Cement is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to DePuy 1 Gentamicin Bone Cement (K023103), Simplex P with Tobramycin Bone Ccment (K014199), St and Endurance Bone Cement (P960001/S003). Endurance Bone Cement (KU14199)
to Class II by the EDA official (P960001/S003). Endurance Bone Cement was down classified to Class II by the FDA effective August 16, 2002.

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

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that converge at the bottom.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2004

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

Rc: K033382

Trade/Devicc Name: Smartset GMV Endurance Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Il Product Code: I.OD Dated: December 29, 2003 Received: December 30, 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, Insting 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 he 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 docs 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2- Ms. Tiffani D. 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,

Mark McMillan

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): __K033382___________________________________________________________________________________________________________________________________________

. . . . .

Device Name: ____SmartSet GMV Endurance Gentamicin Bone Cement_ Indications for Use:

Smartset GMV Endurance 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 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)

Craive

for Mark A. Milliken

Page __ of ___________________________________________________________________________________________________________________________________________________________________