SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT

K063857 · Howmedica Osteonics Corp. · MBB · Feb 26, 2007 · Orthopedic

Device Facts

• Record ID: K063857
• Device Name: SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
• Applicant: Howmedica Osteonics Corp.
• Product Code: MBB · Orthopedic
• Decision Date: Feb 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Simplex P SpeedSet with Tobramycin bone cement is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.

Device Story

Radiopaque PMMA bone cement premixed with antibiotic (tobramycin); supplied as sterile powder pouch and liquid monomer ampoule. Applied digitally or via syringe by surgeons in clinical settings. Functions as fixation medium for prostheses in two-stage revision arthroplasty. Working time ~5.36 minutes; dough time ~2 minutes; setting time ~9.6 minutes. Single-use.

Technological Characteristics

PMMA bone cement; radiopaque; premixed with tobramycin. Components: 41.1g sterile polymeric powder, 20.0ml sterile monomer ampoule. Manual application via syringe or digital. Single-use.

Indications for Use

Indicated for fixation of prostheses to living bone during the second stage of a two-stage revision for total joint 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

• Simplex P with Tobramycin bone cement (K014199)
• Simplex P SpeedSet bone cement (K053198)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness Simplex™ P SpeedSet Bone Cement with Tobramycin

FEB 2 6 2007

| Proprietary Name: | Simplex™ P SpeedSet with Tobramycin Bone Cement |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Antibiotic PMMA Bone Cement |
| Classification Name and Reference | Polymethylmethacrylate (PMMA) bone cement<br>21 CFR §888.3027 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 MBB - Polymethylmethacrylate (PMMA) bone cement. |
| Device Manufacturer: | Howmedica International S. de R.L.<br>Raheen Business Park, Limerick, Ireland |
| For Information contact: | Tiffani Rogers<br>Regulatory Affairs Specialist<br>Stryker Orthopaedics<br>325 Corporate Drive<br>Mahwah, New Jersey 07432<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Summary Prepared: | February 15, 2007 |

## Device Description

116

Simplex P SpeedSet with Tobramycin Bone Cement is a radiopaque bone cement premixed with antibiotic capable of being applied digitally and with a syringe. The cement will be available in 10-pack or 1-pack dispensers, with each individual pack containing one powder pouch of 41.1 g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use. The working time of the Simplex P SpeedSet with Tobramycin Bone Cement is approximately 5.36 minutes, with a dough time of 2 pouristian and a setting time of 9.6 minutes.

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## Indications For Use:

Simplex P SpeedSet with Tobramycin bone cement is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.

## Substantial Equivalence:

The Simplex P SpeedSet with Tobramycin bone cement has the same indications, same liquid monomer and similar powder component as Simplex P with Tobramcyin bone cement (K014199 cleared 06 May 2003). The handling properties of Simplex P SpeedSet with Tobramycin are the same as those with Simplex P SpeedSet (K053198 cleared 26 January 2006). Howmedica Osteonics Corp. believes the Simplex P SpeedSet with Tobramycin bone cement to be substantially equivalent to Simplex P with Tobramycin and Simplex P SpeedSet bone cements.

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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 an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2007

Stryker Orthopaedics % Ms. Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K063857

Trade/Device Name: Simplex® P SpeedSet with Tobramycin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: MBB Dated: December 22, 2006 Received: December 28, 2006

Dear Ms. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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. Tiffany 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/industry/support/index.html.

Sincerely vours.

Barbara Buchner

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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510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications

Simplex P SpeedSet with Tobramycin Bone Cement is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty.

Prescription Use X (Per 21 CFR 801.109)

OR Over-the-Counter Use

(Please Do Not Write Below This Line - Continue on Another Page if Needed)

enbare buedun

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

510(k) Number