SIMPLEX P BONE CEMENT

K062553 · Stryker Orthopaedics · LOD · Jan 8, 2007 · Orthopedic

Device Facts

• Record ID: K062553
• Device Name: SIMPLEX P BONE CEMENT
• Applicant: Stryker Orthopaedics
• Product Code: LOD · Orthopedic
• Decision Date: Jan 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Simplex™ P bone cement will be indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, or revision of a previous Simplex™ P bone cement is also indicated for the fixation of arthroplasty. pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.

Device Story

Simplex™ P Bone Cement is a radiopaque PMMA-based bone cement used for the fixation of prostheses to living bone. The device consists of a sterile polymeric powder and a sterile liquid monomer, which are mixed to form the cement. It is applied by a surgeon during orthopaedic procedures using digital application or a syringe. The cement hardens in situ to provide mechanical fixation between the prosthesis and the bone. It is intended for single-use in clinical settings. By stabilizing the prosthesis, the cement facilitates joint reconstruction and addresses bone loss or fracture recalcitrance, aiming to restore joint function and reduce pain for the patient.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical formulation to the previously approved PMA device.

Technological Characteristics

Radiopaque PMMA (polymethylmethacrylate) bone cement. Supplied as a two-component system: sterile polymeric powder and sterile liquid monomer. Applied via manual digital application or syringe. Single-use.

Indications for Use

Indicated for patients undergoing orthopaedic musculoskeletal procedures requiring prosthesis fixation due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction, or pathological fractures where conventional procedures are ineffective.

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 Bone Cement (PMA N17004)

Submission Summary (Full Text)

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

K062553

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

JAN - 8 2007

| Proprietary Name: | Simplex™ P Bone Cement |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | PMMA Bone Cement |
| Classification Name and Reference | Polymethylmethacrylate (PMMA) bone<br>cement<br>21 CFR §888.3027 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 LOD - Polymethylmethacrylate (PMMA)<br>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: | August 28, 2006 |

## Device Description

Simplex™ P Bone Cement is a radiopaque bone cement 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 40.0g unit of sterile polymeric powder and one 20.0ml ampoule of sterile monomer, for single-use.

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

## Indications For Use:

Simplex™ P bone cement will be indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, or revision of a previous Simplex™ P bone cement is also indicated for the fixation of arthroplasty. pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.

## Substantial Equivalence:

The Simplex™ P powder and liquid monomer formula have not been modified and will be the same as what was approved in PMA N17004.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN - 8 2007

Re: K062553

Trade/Device Name: Simplex™ P Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: November 13, 2006 Received: November 22, 2006

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.

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

Page 2 - Ms. 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/industry/support/index.html.

Sincerely yours

for
Mark N. Malkerson

Mark N Aelkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications

Simplex P bone cement will be indicated for fixation of prostheses to living bone during orthopaedic musculoskeletal procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, or revision of a previous Simplex™ P bone cement is also indicated for the fixation of arthroplasty. pathological fractures where loss of bone substance or recalcitrance of the fracture renders more conventional procedures ineffective.

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)

Polo Rz

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

**510(k) Number** V062553