BLOCK CEMENT RESTRICTOR (CR) - TITANIUM

K013014 · Medtronic Sofamor Danek, Inc. · JDK · Oct 4, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013014
• Device Name: BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Oct 4, 2001
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic Sofamor Danek Block Cement Restrictor (CR) - Titanium is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement. The Block CR-Titanium is NOT intended for any spinal indications.

Device Story

The BLOCK CR - TITANIUM is a tapered titanium alloy block used as a cement restrictor in orthopedic surgeries. It is implanted by a surgeon into the femoral canal or tibial plateau during hip or knee replacement procedures to contain PMMA bone cement. The device functions as a physical barrier to prevent cement migration beyond the intended site. It is a passive, non-electronic implant.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tapered block design; manufactured from titanium alloy per ASTM F136 or ISO 5832-3. Passive implant; no energy source, software, or connectivity.

Indications for Use

Indicated for use as a cement restrictor in orthopedic surgeries involving the femoral canal and tibial plateau 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

• TITANIUM CEMENT RESTRICTOR (K003718)

Submission Summary (Full Text)

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K01-3014

# OCT - 4 2001

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## BLOCK CEMENT RESTRICTOR (CR) - TITANIUM 510(k) Summary September 2001

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

### Proposed Proprietary Trade Name: II.

BLOCK CR - TITANIUM

#### III. Device Description:

The BLOCK CR - TITANIUM is a tapered block that is titanium. The device is intended to be used in conjunction with standard PMMA cement.

The BLOCK CR - TITANIUM 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 the alternative design. All other aspects of the device including material, indications for use, and fundamental scientific technology are the same as the previous cleared TITANIUM CEMENT RESTRICTOR.

#### IV Intended Use:

The BLOCK CR-Titanium 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 BLOCK CR-Titanium is NOT intended for any spinal indications.

#### Substantial Equivalence: V.

The BLOCK CR - TITANIUM was demonstrated to be substantially equivalent to previously cleared devices such as TITANIUM CEMENT RESTRICTOR (K003718). A Design Review for the device was provided in this submission.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 4 2001

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

Re: K013014 Block Cement Restrictor (CR) - Titanium Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: September 5, 2001 Received: September 7, 2001

Dear Dr. Treharne:

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.

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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 (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.

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.

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: K013014

Medtronic Sofamor Danek Block Cement Restrictor (CR) - Titanium Device Name:

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

The Medtronic Sofamor Danek Block Cement Restrictor (CR) - Titanium is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement.

The Block CR-Titanium is NOT intended for any spinal indications.

for Mark n Mulkerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. ***_***_ K013014

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________