SMARTSET MV BONE CEMENT

K081155 · DePuy Orthopaedics, Inc. · LOD · May 14, 2008 · Orthopedic

Device Facts

• Record ID: K081155
• Device Name: SMARTSET MV BONE CEMENT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: May 14, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SmartSet MV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Device Story

SmartSet MV Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) based bone cement. It is used by surgeons during arthroplasty procedures to secure metal or polymeric prostheses to living bone. The cement acts as a fixation medium to stabilize the implant within the musculoskeletal system. It is intended for clinical use in orthopaedic surgical settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and formulation characteristics equivalent to predicate devices.

Technological Characteristics

Self-curing, radiopaque, polymethylmethacrylate (PMMA) based bone cement. Class II device (21 CFR 888.3027, Product Code LOD).

Indications for Use

Indicated for fixation of prostheses to living bone in patients undergoing orthopaedic musculoskeletal surgery due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma, or revision arthroplasty.

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 MV Endurance Bone Cement (P960001)
• SmartSet HV Bone Cement (K023012)

Submission Summary (Full Text)

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## 510(k) Summary

K081155
MAY 14 2008

| Date Prepared: | 21 April 2008 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Sponsor: | DePuy Orthopaedics, Inc<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581 - 0988 |
| Establishment Registration<br>No: | 1818910 |
| Contact Person: | Suzana Otaño<br>Project Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name of Device: | SmartSet MV Bone Cement |
| Common Name: | Bone cement |
| Classification Name: | Bone cement (21 CFR 888.3027, Product Code LOD) |
| Equivalent to: | SmartSet MV Endurance Bone Cement (P960001, previously<br>branded Endurance Bone Cement)<br>SmartSet HV Bone Cement (K023012) |
| Device Description: | SmartSet MV Bone Cement is a self-curing, radiopaque,<br>polymethylmethacrylate based cement. The bone cement is<br>used for securing a metal or polymeric prosthesis to living<br>bone in arthroplasty procedures. |
| Intended Use: | SmartSet MV Bone Cement is indicated for the fixation of<br>prostheses to living bone in orthopaedic musculoskeletal<br>surgical procedures for rheumatoid arthritis, osteoarthritis,<br>traumatic arthritis, osteoporosis, avascular necrosis,<br>collagen disease, severe joint destruction secondary to<br>trauma or other conditions, and revision of previous<br>arthroplasty. |
| Technological<br>Characteristics: | The technological characteristics of the SmartSet MV Bone<br>Cement are equivalent to the predicate devices. |

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Substantial Equivalence:

The indications, intended use, formulation and finished product specifications of the SmartSet MV Bone Cement are equivalent to the predicate devices.

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Special 510(k) SmartSet MV Bone Cement April 2008

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is composed of thick, black lines. Surrounding the eagle is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

MAY 1 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Suzana Otano Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, IN 46581-0988

Re: K081155

Trade/Device Name: SmartSet MV Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: April 21, 2008 Received: April 23, 2008

Dear Ms. Otano:

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. Suzana Otano

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

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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## Indications for Use Statement

510(k) Number:

Device Name: SmartSet MV Bone Cement

Indications For Use:

SmartSet MV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

× Prescription Use

(Per 21 CFR 801 Subpart D)

1. 1.

AND/OR Over-the-Counter

(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)

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

510(k) Number K081155

Special 510(k) SmartSet MV Bone Cernent April 2008

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