MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH

K040364 · Porex Surgical, Inc. · FTM · Jun 30, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040364
• Device Name: MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
• Applicant: Porex Surgical, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MEDPOR Biomaterial with Embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.

Device Story

Device consists of titanium mesh encapsulated within high-density polyethylene (MEDPOR) biomaterial. Available in three configurations: titanium mesh within thin solid polyethylene coating; titanium mesh within porous polyethylene sheet with nonporous barrier; or titanium mesh within porous polyethylene sheet. Used by surgeons in clinical settings for craniofacial reconstruction, cosmetic procedures, and trauma repair. Implant provides structural support and contouring for non-weight bearing applications. Surgeon shapes and implants device to restore facial anatomy. Benefits include biocompatibility of MEDPOR and structural reinforcement provided by embedded titanium mesh.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: High-density polyethylene (MEDPOR) and titanium mesh. Configurations: Titanium mesh encapsulated in solid polyethylene, porous polyethylene with nonporous barrier, or porous polyethylene. Application: Non-weight bearing craniofacial reconstruction. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring non-weight bearing craniofacial reconstruction, cosmetic surgery, or repair of craniofacial trauma.

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

• MEDPOR Surgical Implant Material
• MEDPOR Barrier Implants
• MEDPOR Barrier Channel Implants
• Other titanium bone meshes currently marketed

Submission Summary (Full Text)

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JUN 3 0 2004

Image /page/0/Picture/1 description: The image shows the logo for Porex Surgical Products Group. The word "POREX" is in large, bold, black letters. Below the word "POREX" is the phrase "SURGICAL PRODUCTS GROUP" in smaller, thinner, black letters. The logo is simple and professional.

510(k) SUMMARY (Amended May 19, 2004)

Manufacturer and Submitter

Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265

Tel: [phone] Fax: [phone]

Contact: Greg Swords e-mail: [e-mail]

Date: February 9, 2004

Trade Name: MEDPOR Craniofacial Implants with Embedded Titanium Mesh

Class II Device 510(k) Number K040364 - - - #FF

Substantially equivalent to:

- MEDPOR® Surgical Implant Material A.
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- MEDPOR® Barrier Implants
MEDPOR® Barrier Implants
MEDPOR® Barrier Channel Implants ்.
- Other titanium bone meshes currently marketed D.

Device description:

This device is a MEDPOR/titanium mesh craniofacial implant available in three configurations: (1) A titanium mesh encapsulated within a thin coating of solid high density polyethylene. (2) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet with a nonporous barrier on one side. (3) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet.

Indications for Use.

MEDPOR Biomaterial with Embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three lines extending from its head.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 3 0 2004

Mr. Greg Swords VP, Technology and Development Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265-1017

Re: K040364

Trade/Device Name: MEDPOR® Craniofacial Implants with Embedded Titanium Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, FTL Dated: February 9, 2004 Received: February 13, 2004

Dear Mr. Swords:

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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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

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Page 2 – Mr. Greg Swords

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for POREX SURGICAL PRODUCTS GROUP. The word "POREX" is in large, bold, black letters. Below the word "POREX" is the phrase "SURGICAL PRODUCTS GROUP" in smaller, thinner, black letters.

INDICATION FOR USE (Amended May 19, 2004)

Applicant: Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265

Tel: [phone] Fax: [phone]

510(k) Number: K 040364

Device Name: MEDPOR Craniofacial Implants with Embedded Titanium Mesh

Indications for Use:

MEDPOR Biomaterial with Embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.

## (PLEASE DO NOT WRITE BELOW THIS LINE)

Muriam C. Provost
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K040364 |
|-----------------------|---------|
| Prescription Use: | X |
| | OR |
| Over the Counter Use: | |