RABEA CEMENT RESTRICTOR

K020836 · Signus Medical, LLC · JDK · Jun 11, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020836
• Device Name: RABEA CEMENT RESTRICTOR
• Applicant: Signus Medical, LLC
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Jun 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RABEAT™ Device is intended to be used in orthopedic surgeries, such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

Device Story

RABEA™ Cement Restrictor is a hollow, PEEK, rounded rectangular frame; features fenestrated surfaces and 1mm toothed spikes on opposite sides. Used in orthopedic surgeries (femoral canal, tibial plateau) during hip stem and total knee replacement. Device acts as a physical barrier to contain PMMA bone cement within the surgical site. Operated by orthopedic surgeons in clinical settings. Benefits patient by preventing cement migration beyond the intended area. Not for spinal use or acetabular cup surgeries.

Clinical Evidence

Bench testing only. Functional and safety testing performed under conditions simulating normal usage to ensure conformance to product specifications. No clinical data presented.

Technological Characteristics

Material: PEEK. Form factor: Hollow, rounded rectangular frame with fenestrated surfaces and 1mm toothed spikes. Function: Mechanical cement restriction. Energy source: None (passive).

Indications for Use

Indicated for use in orthopedic surgeries, specifically femoral canal and tibial plateau procedures during hip stem and total knee replacement. Contraindicated for acetabular cup surgeries and 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

• RABEAT™ Titanium Cement Restrictor (K990345)
• Medtronic Sofamor Danek Cement Restrictor (K013663)

Submission Summary (Full Text)

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K020836

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## JUN 1 1 2002

## 510(k) Summary for the RABEA Cement Restrictor Device

| Submitter: | SIGNUS Medical LLC<br>7140 Derby Drive<br>Chanhassen, MN 55317 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Thomas Hoghaug<br>SIGNUS Medical LLC<br>7140 Derby Drive<br>Chanhassen, MN 55317 |
| Date Prepared: | June 3, 2002 |
| Trade Name: | RABEAT™ Cement Restrictor |
| Classification Name:<br>and Number: | Cement Restrictor<br>Class II, 21 CFR 878.3300 |
| Product Code: | JDK |
| Predicate Device(s): | The RABEAT™ Cement Restrictor is substantially<br>equivalent to:<br><ul><li>RABEAT™ Titanium Cement Restrictor (K990345)</li><li>Medtronic Sofamor Danek Cement Restrictor (K013663)</li></ul> |
| Device Description: | The RABEAT™ Cement Restrictor is a hollow, PEEK<br>rounded rectangular frame with fenestrated surfaces on all<br>sides and 1mm toothed spikes on opposite sides. The<br>device is intended to be used in conjunction with standard<br>PMMA cement. |
| Intended Use: | The RABEAT™ Device is intended to be used in orthopedic<br>surgeries, such as those involving the femoral canal and<br>tibial plateau in hip stem and total knee replacement. This<br>device is not appropriate for acetabular cup surgeries, nor is<br>it intended for any spinal indications. |

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Functional and Safety Testing:

Functional and safety testing of the RABEA IM Cement Restrictor Device consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications. The results of the examination and testing were successful and did not raise any issucs of safety and effectivencss of the device.

Conclusion:

The RABEA™ Cement Restrictor Device is substantially cquivalent to the RABEA™ Titanium Cement Restrictor (K990345) and the Medtronic Sofamor Danek Cement Restrictor (K013663) based upon the devices' similarities in functional design and indications for use.

# KO20836

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 1 2002

Mr. Thomas Hoghaug Managing Director SIGNUS Medical LLC 7140 Derby Drive Chanhassen, Minnesota 55317

> K020836 RABEA™ Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: March 12, 2002 Received: March 14, 2002

Dear Mr. Hoghaug:

Re:

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 -- Mr. Thomas Hoghaug

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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K02.0.836

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## Indications for Use Page

Device Name: RABEA™ Cement Restrictor

Indications for Use: The RABEA™ Cement Restrictor is intended to be used in orthopedic surgeries, such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. This device is not appropriate for acetabular cup surgeries, nor is it intended for any spinal indications.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Millman

(Division Sign-Off Division of General, Restorative and Neurological Devi

510(k) Number_