METRONIC SOFAMOR DANEK CEMENT RESTRICTOR

K011998 · Medtronic Sofamor Danek, Inc. · JDK · Jul 26, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011998
• Device Name: METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Jul 26, 2001
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2

Intended Use

The Medtronic Sofamor Danek Cement Restrictor 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. The Medtronic Sofamor Danek Cement Restrictor is NOT intended for any spinal indications.

Device Story

The Medtronic Sofamor Danek Cement Restrictor is a mechanical implant used during orthopedic procedures, specifically hip stem and total knee replacements. It is inserted into the femoral canal or tibial plateau to act as a barrier, restricting the flow of bone cement during the implantation of prosthetic components. The device is used by orthopedic surgeons in an operating room setting. By preventing the distal migration of bone cement, the restrictor ensures proper cement mantle formation, which is critical for the secure fixation of the orthopedic implant. The device is strictly contraindicated for spinal applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical cement restrictor; intended for orthopedic surgical use. No electronic, software, or energy-based components. Materials and specific ASTM standards not disclosed in the provided text.

Indications for Use

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

Submission Summary (Full Text)

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AUG 3 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K011998 Cement Restrictor Regulation Number: 878.3300 Regulatory Class: II Product Code: JDK Dated: June 25, 2001 Received: June 27, 2001

Dear Dr. Treharne:

This letter corrects our substantially equivalent letter of July 26, 2001.

We have reviewed your Section 510(k) notification of intent to market the device referenced we have toviously of the bevice is substantially equivalent (for the indications for use above and we nave determined the arteted predicate devices marketed in interstate commerce stated in the onerobate, to regary ont date of the Medical Device Amendments, or to devices that provisions of the recordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (ree). Tot may) ansieses, described below. The general controls provisions of the provisions of the Are and 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 The Office of Device Erantation use not identified in the proposed labeling and that such use device with be assed for an meniaso ardance with Section 513(i)(1)(E) of the Act, the following court each intime "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.

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## Page 2 - Richard W. Treharne, Ph.D.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Владева

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

Enclosure

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Page 3 – Richard W. Treharne, Ph.D.

510(k) Number: K011998

Medtronic Sofamor Danek Cement Restrictor Device Name:

FDA's Statement of the Indications For Use for Device:

The Medtronic Sofamor Danek Cement Restrictor 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.

The Medtronic Sofamor Danek Cement Restrictor is NOT intended for any spinal indications.

for Mark N. Mulkerron

I. Restorative and Neurologic 011998

510(k) Number

Prescription Use_ OR (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________