MODIFICATION TO VERSABOND BONE CEMENT

K033509 · Smith & Nephew, Inc. · LOD · Nov 28, 2003 · Orthopedic

Device Facts

• Record ID: K033509
• Device Name: MODIFICATION TO VERSABOND BONE CEMENT
• Applicant: Smith & Nephew, Inc.
• Product Code: LOD · Orthopedic
• Decision Date: Nov 28, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VersaBond Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, traumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the femur, osteoporosis, secondary severe joint destruction following trauma or other conditions, and revision of previous arthroplasty procedures.

Device Story

VersaBond Bone Cement is a two-component system consisting of a polymer powder and a monomer liquid. When mixed, these components form a radiopaque, rapidly setting bone cement. The device is used by surgeons in clinical settings during arthroplastic procedures to fix plastic and metal prosthetic implants to living bone. The cement provides mechanical fixation, enabling reconstruction of joints affected by degenerative or traumatic conditions. It is a manual, non-automated surgical material.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical chemical formulation and design to the predicate device.

Technological Characteristics

Two-component PMMA bone cement (polymer powder and monomer liquid). Radiopaque. Identical chemical formulation to predicate K001160. Manual mixing process. No electronic or software components.

Indications for Use

Indicated for patients undergoing hip, knee, or other joint arthroplasty requiring fixation of prosthetic components to bone due to osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, femoral nonunion, osteoporosis, or post-traumatic joint destruction; also indicated for 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

• K001160

Submission Summary (Full Text)

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

| NOV 28 2003 | 510(k) Summary of Safety and Effectiveness<br>VersaBond® Bone Cement | |
|-------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Submitted By: | | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 Brooks Road<br>Memphis, TN 38116 |
| Date: | | November 5, 2003 |
| Contact Person: | | David Henley<br>Senior Clinical/Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone] |
| Proprietary Name: | | VersaBond® Bone Cement |
| Common Name: | | Polymethylmethacrylate (PMMA) Bone Cement |
| Classification Name and Reference: | | Polymethylmethacrylate (PMMA) Bone Cement<br>21 CFR 888.3027, Class II |
| Device Product Code and Panel Code: | | LOD/Orthopedics/87 |

Device Description:

VersaBond Bone Cement consists of two separate components: polymer powder and monomer liguid. The two components are packaged together and are pre-measured, sterilized components which, when mixed, form a radiopaque, rapidly setting bone cement.

## Intended Use:

VersaBond Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, traumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the femur, osteoporosis, secondary severe joint destruction following trauma or other conditions, and revision of previous arthroplasty procedures.

## Technological Characteristics:

The chemical formulation of VersaBond Bone Cement, that is the subject of this submission, is identical to that of the device cleared under K001160. Similarities include the identical constituents for the bone cement / liquid monomer and identical indications for use. The device is designed to incorporate identical or very similar physical and mechanical properties.

## Substantial Equivalence Information:

The indications for use, chemical formulation, and design features of VersaBond Bone Cement are substantially equivalent to the device cleared under K001160.

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with three overlapping wings or feathers. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the top half of the circle, following its curvature.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 28 2003

Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116

Re: K033509

Trade/Device Name: Versabond Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: November 5, 2003 Received: November 6, 2003

Dear Mr. Henley:

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. Iisting 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 - Mr. David Henley

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 N. Wilkerson

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 Statement VersaBond® Bone Cement

KO33509 510(k) Number (if known): __________

Device Name: VersaBond® Bone Cement

Indications for Use:

VersaBond® Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the femur, osteoporosis, secondary severe joint destruction following trauma or other conditions, and revision of previous arthroplasty procedures.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Millham

1. Fiestorative and Neurological Devices

" " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use_ (Optional Format 1-2-96)