CADENCE CEMENT RESTRICTOR

K022218 · Spinal Concepts, Inc. · JDK · Aug 12, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022218
• Device Name: CADENCE CEMENT RESTRICTOR
• Applicant: Spinal Concepts, Inc.
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Aug 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cadence™ Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not intended for any spinal indications. The safety and effectiveness of this device WHEN IMPLANTED in the spine have not been established.

Device Story

Cadence™ Cement Restrictor is a hollow, tapered titanium alloy device featuring teeth on two opposing flat sides. Used in orthopedic surgery to hold bone cement (PMMA) within the diaphyseal canal during cemented arthroplasty (hip stem and total knee replacement). Implanted by surgeons to prevent cement migration. Device provides mechanical restriction of cement flow; benefits include optimized cement mantle placement. No spinal use permitted.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium alloy (ASTM F136). Design: Hollow, tapered, with teeth on two opposing flat sides. Function: Mechanical cement restriction. No software or electronic components.

Indications for Use

Indicated for use as a cement restrictor in orthopedic surgeries, specifically femoral canal and tibial plateau procedures during hip stem and total knee replacement. Contraindicated for spinal indications.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Medtronic Sofamor Danek Cement Restrictor (K010528)
• Medtronic Sofamor Danek Cement Restrictor (K003718)
• Medtronic Sofamor Danek Cement Restrictor (K010529)

Submission Summary (Full Text)

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

#### K022218

page lot 1

#### 510(K) Summary

| Submitted By: | David M. Hooper, PhD<br>Manager, Clinical & Regulatory Affairs<br>Spinal Concepts, Inc.<br>12012 Technology Blvd., Suite 100<br>Austin, TX 78727<br>512-918-2700<br>May 22, 2001 |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Trade Name: | Cadence™ Cement Restrictor |
|-------------------------------|------------------------------------|
| Proposed Classification Name: | Prosthesis, Hip, Cement Restrictor |
| Product Code: | JDK (21CFR 878.3300) |

Predicate Devices: The Cadence™ Cement Restrictor is similar in terms of intended use, materials of construction, and technological characteristics to the predicate devices reviewed, the Medtronic Sofamor Danek Cement Restrictor (K010528) and its Medtronic Sofamor Danek predicates (K003718 and K010529).

Device Description: The Cadence™ Cement Restrictor is a hollow device with teeth on two opposing flat sides. The device is crafted of titanium alloy (ASTM F136) and is offered in a tapered style of various sizes. The device is used to hold bone cement (PMMA) in the diaphyseal canal in patients requiring a cemented arthroplasty device.

Intended Use: The Cadence™ Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

This device is not intended for any spinal indications. The safety and effectiveness of this device WHEN IMPLANTED in the spine have not been established.

Substantial Equivalence: A design review was provided to demonstrate that the Cadence™ Cement Restrictor is substantially equivalent to previously cleared devices such as the Medtronic Sofamor Danek Cement Restrictor(s) (K010528, K003718 and K010529).

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

Page 1 - Dr. David Hooper

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

AUG 1 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David M. Hooper, Ph.D. Manager, Clinical & Regulatory Affairs Spinal Concepts Incorporated 12012 Technology Blvd, Suite 100 Austin, Texas 78727

Re: K022218

CADENCE TITANIUM Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: July 3, 2002 Received: July 9, 2002

Dear Dr. Hooper:

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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:

WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

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

### Page 2 - David M. Hooper, Ph.D.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

B

Bernard Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

### INDICATIONS FOR USE STATEMENT

Page 1 of 1

# 510(k) Number (if known):

Device Name: Spinal Concepts, Inc. Cadence™ Cement Restrictor

Indications for Use:

The Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use: (Per 21 CFR 801.109) Over-The-Counter: (Optional Format 1-2-96)

Mark A. Milliken

(Division Sign-Off) (Division Sign-Oral, Restorative and Neurological Devices

510(k) Number -