RABEA DEVICE, MODEL PXXXXXX

K990345 · Signus Medizintechnik GmbH · JDK · Jul 30, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990345
• Device Name: RABEA DEVICE, MODEL PXXXXXX
• Applicant: Signus Medizintechnik GmbH
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Jul 30, 1999
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RABEA™ Cement Restrictor Device 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 appropriate for acetabular cup surgeries.

Device Story

RABEA Cement Restrictor Device is a hollow, titanium, rounded rectangular frame with fenestrated surfaces and 1 mm toothed spikes. Used in orthopedic surgery to restrict PMMA bone cement within the femoral canal or tibial plateau during hip or knee replacement. Device is implanted by a surgeon to prevent cement migration. Titanium construction provides structural integrity for containment. Not for use in acetabular cup or spinal procedures.

Clinical Evidence

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

Technological Characteristics

Titanium, hollow, rounded rectangular frame, fenestrated surfaces, 1 mm toothed spikes. Mechanical device for 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 in hip stem and total knee replacement. Contraindicated for acetabular cup surgeries and 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

• Osteonics PTII Cement Spacer (K914406)
• Motech Surgical Mesh (K900138)

Submission Summary (Full Text)

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JUL 30 1999

.

# ¥990345

Attachment 2

510(k) Summary

### 510(K) SUMMARY

| SUBMITTER: | SIGNUS Medizintechnik GmbH<br>Rannenbergring 54<br>D-63755 Alzenau<br>Germany |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Mr. Thomas Hoghaug<br>Newport Medical International<br>27660 Woodside Road<br>Shorewood, MN 55331<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | April 30, 1999 |
| TRADE NAME: | RABEATM Cement Restrictor Device |
| CLASSIFICATION NAME<br>and NUMBER:<br>PRODUCT CODE: | Surgical Mesh<br>Class II, 21 CFR 878.3300<br>JDK |
| PREDICATE DEVICE(S): | The RABEA™ Cement Restrictor Device is substantially<br>equivalent to the Osteonics PTII Cement Spacer which was<br>cleared via premarket notification K914406 on December 20,<br>1991, and the Motech Surgical Mesh which was cleared for use<br>as a cement restrictor via premarket notification K900138 on<br>March 20, 1990. |
| DEVICE DESCRIPTION: | The RABEATM Cement Restrictor Device is a hollow, titanium,<br>rounded rectangular frame with fenestrated surfaces on all sides<br>and 1 mm toothed spikes on opposite sides. The device is<br>intended to be used in conjunction with standard PMMA cement. |
| INTENDED USE: | The RABEATM Cement Restrictor Device is intended for use as a<br>cement restrictor in orthopedic surgeries such as those involving<br>the femoral canal and tibial plateau in hip stem and total knee<br>replacement. This device is not appropriate for acetabular cup<br>surgeries. |
| FUNCTIONAL &<br>SAFETY TESTING: | Functional and safety testing of the RABEA™ Cement<br>Restrictor Device consisted of examination of the function of the<br>device under conditions similar to those found in normal usage<br>and testing to ensure conformance to product specifications. The |

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results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device.

#### CONCLUSION:

The RABEA™ Cement Restrictor Device is substantially equivalent to the Osteonics PTII Cement Spacer which was cleared via premarket notification K914406 on December 20, 1991, and the Motech Surgical Mesh which was cleared for use as a cement restrictor via premarket notification K900138 on March 20, 1990, based upon the devices' similarities in functional design, materials and indications for use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2001

Mr. Thomas Hoghaug Newport Medical International 27660 Woodside Road Shorewood, Minnesota 55331

Re: K990345

> Tradc Namc: RABEATM Cement Restrictor Regulation Number: 878.3350 Regulatory Class: II Product Code: JDK Dated: April 30, 1999 Received: May 3, 1999

Dear Mr. Hoghaug:

This letter corrects our substantially equivalent letter of July 30, 1999.

We have reviewed your Section 510(k) 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). 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 p. visions of equirements 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 (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/cdrl/dsma/dsmamain.html".

Sincerely vours

H. Ehlers

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

Enclosure

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## Indications for Use Page

K990345. 510(k) Number (if known):

Device Name:

RABEA™ Cement Restrictor Device

ALUUESI INC

Indications for Use:

Indications for Use.
The RABEAT* Cement Restrictor Device is intended for use as a cement restrictor in orthopedic The RABEATK Cement Restricter Device is intended for use as a cement results are and total provention
surgeries such as those involving the femoral canal and tibial placeries Inc. 11:22:00
surgeries such as those involving the femoral canal and tions. Included in the surgeries.
replacement. This device is not appropriate for acctabular cup surger

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K990345 |

Prescription Use
(Per 21 CFR 801.109)

C