PEEK CEMENT RESTRICTOR X-BOX

K041583 · Innovasis, Inc. · JDK · Jul 22, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041583
• Device Name: PEEK CEMENT RESTRICTOR X-BOX
• Applicant: Innovasis, Inc.
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Jul 22, 2004
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The INNOVASIS 'X-Box' PEEK Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial canal in hip stem and total knee replacement. 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

Device Story

The X-Box is a non-load bearing, hollow, rectangular frame implant made of PEEK; features fenestrated sides and exterior ribs to aid retention in the medullary canal. Used in orthopedic surgery (femoral/tibial canals) to prevent PMMA bone cement migration during hip or knee replacement. Implanted by surgeons; functions as a physical barrier (cement plug). Includes embedded titanium wires for radiological visualization. No mechanical testing performed due to non-load bearing nature.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Material: PEEK-OPTIMA (ASTM F 2026-00) with embedded 6-4 Alloy Titanium (ASTM F 136) radiological markers. Form factor: hollow rectangular frame with fenestrated sides and exterior ribs. Non-load bearing. No software or energy source.

Indications for Use

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

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

• Spinal Concepts, Inc. (K031837, K031318, & K021719)
• Medtronic Sofamor Danek (K0010528)

Submission Summary (Full Text)

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# JUL 2 2 2004

#### 510(k) Summary of Safety and Effectiveness

#### SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

| Name of Firm: | Innovasis, Inc.<br>997 East 3900 South, Suite 103<br>Salt Lake City, Utah 84124 |
|--------------------------------------|-------------------------------------------------------------------------------------------|
| 510(k) Contact: | Brent A. Felix<br>Same address as above |
| Trade Name: | PEEK Cement Restrictor "X-Box" |
| Common Name: | Cement Restrictor |
| Classification: | Prosthesis, Hip, Cement Restrictor.<br>Class II (see 21CRF, Sec. 888.3300) |
| Device Product Code: | JDK. The Panel code is 87. |
| Substantially<br>Equivalent Devices: | Spinal Concepts, Inc. (K031837, K031318, & K021719)<br>Medtronic Sofamor Danek (K0010528) |

## Device Description:

The INNOVASIS 'X-Box' PEEK Cement Restrictor is an implant system for use as a non-load bearing 'cement plug' in orthopedic surgery.

The design of the X-Box include rectangular components of different cross-sectional sizes to accommodate various configurations in the midsection femoral/tibial diaphyseal canal. These various size components will aid in placement and retention of the device in the medullary canal in order to prevent the migration of PMMA cement into the canal for patients receiving orthopedic cemented femoral hip or tibial total knee components. The X-Box is a hollow, PEEK material, rectangular frame with fenestrated sides and exterior ribs.

The device is intended to be used in conjunction with standard PMMA bone cement.

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#### Intended Use:

The INNOVASIS 'X-Box' PEEK Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial canal in hip stem and total knee replacement.

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

#### Material:

The Innovasis 'X-Box' PEEK Cement Restrictor is made from PEEK -OPTIMA™ (Polyetheretherketone) material according to ASTM F 2026-00 with embedded 6-4 Alloy Titanium (ASTM F 136) wires as radiological markers.

These materials are proven to be biocompatible as implant materials.

## Performance Data:

No mechanical tests were performed to support this application. The Innovasis PEEK Cement Restrictor is a non-load bearing device.

#### Basis of Substantial Equivalence:

The Innovasis 'X-Box'' PEEK Cement Restrictor is similar to the predicate Spinal Concepts. Inc. (K031837. K031318. & K021719) and Medtronic Sofamor Danek (K010528) with respect to technical characteristics and performance.

#### Summary of Safety and Effectiveness:

The Innovasis "X-Box" PEEK Cement Restrictor system is shown to be safe and effective for use as a cement plug for use in orthopedic total hip and knee implant replacements.

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Image /page/2/Picture/1 description: The image is a black and white emblem. The emblem is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the emblem is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 22 2004

Mr. Brent A. Felix President Innovasis. Inc. 997 East 3900 South Suite 103 Salt Lake City, Utah 84124

Re: K041583

Trade/Device Name: PEEK Cement Restrictor "X-Box" Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: JDK Dated: June 9, 2004 Received: June 11, 2004

Dear Mr. Felix:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 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 labeling 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. Brent A. Felix

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I loast note that the above these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate I he i Dri inding of basification for your device and permits your device to proceed to the ucerice results in a classification of to begin marketing your device as described in your Section market. "This letter will aton if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified possible in the 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 r read be actived a determination that your device complies with other requirements of the Act that I Drinas Intactions and regulations administered by other Federal agencies. You must or any I odera: blacked and st 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Alwaton MD for

Donna-Bea Tillman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the text "INNOVASIS, INC." in a bold, serif font. The text is black and appears to be a company name. The letters are large and spaced closely together, giving the text a strong visual presence. There is a horizontal line underneath the text.

Salt Lake City, Utah 84124 [phone] [phone] Fax

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# 510(k) NUMBER: __ Ko4 158 3 DEVICE NAME: PEEK CEMENT RESTRICTOR INDICATIONS FOR USE:

The INNOVASIS 'X-Box' PEEK Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial canal in hip stem and total knee replacement.

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.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|----|----------------------|
| Prescription Use | OR | Over-the-Counter-Use |
| (Per 21 CFR 801.109) | | |

(Optional Format)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

K041583

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