MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR

K012255 · Medtronic Sofamor Danek, Inc. · JDK · Aug 1, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012255
• Device Name: MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Aug 1, 2001
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic Sofamor Danek CEMENT RESTRICTOR is intended for use as a cement restrictor in orthopaedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

Device Story

Hollow, cylindrical titanium alloy frame with tapered surface; used as cement restrictor in orthopedic surgeries (femoral canal/tibial plateau). Implanted by surgeons during hip stem or total knee replacement to contain PMMA bone cement. Device provides physical barrier within bone canal; prevents cement migration; ensures proper cement mantle formation. Not for spinal use.

Clinical Evidence

No clinical data provided; substantial equivalence based on design review and technological comparison.

Technological Characteristics

Titanium alloy (ASTM F136 or ISO 5832-3); hollow cylindrical frame with tapered surface; mechanical implant; non-electronic; non-software.

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 all 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 (K003718)

Submission Summary (Full Text)

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1 2001 AUG

# Medtronic Sofamor Danek CEMENT RESTRICTOR 510(k) Summary July 2001

Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 [phone]

#### Proposed Proprietary Trade Name: II.

Medtronic Sofamor Danek CEMENT RESTRICTOR

## III. Device Description:

The Medtronic Sofamor Danek CEMENT RESTRICTOR is a hollow, titanium and cylindrical frame with a tapered surface. The device is intended to be used in conjunction with standard PMMA cement.

The Medtronic Sofamor Danek CEMENT RESTRICTOR implants are manufactured from titanium alloy as described by ASTM F136 or ISO 5832-3.

The purpose of this submission is to obtain clearance for a modified geometry. All other aspects of the device including indications for use are the same as the previous cleared Medtronic Sofamor Danek CEMENT RESTRICTOR.

#### Intended Use: IV

The Medtronic Sofamor Danek CEMENT RESTRICTOR is intended for use as a cement restrictor in orthopaedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

#### V. Substantial Equivalence:

The THREADED BULLET CEMENT RESTRICTOR was demonstrated to be substantially equivalent to the previously cleared device, Medtronic Sofamor Danek CEMENT RESTRICTOR (K003718). A Design Review for the modified device was provided in this submission.

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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

K012255 Re: Medtronic Sofamor Danek Cement Restrictor Regulation Number: 878.3300 Regulatory Class: II Product Code: JDK Dated: July 10, 2001 Received: July 18, 2001

Dear Dr. Treharne:

This letter corrects our substantially equivalent letter of August 1, 2001.

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally of (s) == is substantially equivalent (for the indications for use above and we nave determined the arteted predicate devices marketed in interstate commerce stated in the cherobate, to legally and date of the Medical Device Amendments, or to devices that prior to may 20, 1978, 1978, 1978, 1977, 1997, 1999, 1999, 1999, 1999, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Pre (ree). "The Act and the limitations described below. The general controls provisions of the provisions of the me the minual 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 Dovice Draiation in the proposed labeling and that such use de vio win be about for anfore, in accordance with Section 513(i)(1)(E) of the Act, the following Court cause natin. 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 sot 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

Sincerely yours,

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

Enclosure

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### 510(k) Number: K012255

Device Name: Medtronic Sofamor Danek Cement Restrictor

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.

Prescription Use_X OR (Per 21 CFR 801.109)

Over-The-Counter Use_

Mark Milkenor
Psitchell Tupro cml

(Division Sign-Of Division of General, Restorative and Neurological Devices

510(k) Number_KO | 225