MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL

K012350 · Porex Surgical, Inc. · FWP · Mar 14, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K012350
• Device Name: MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
• Applicant: Porex Surgical, Inc.
• Product Code: FWP · General, Plastic Surgery
• Decision Date: Mar 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3550
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

MEDPOR® Plus Surgical Implants in block, sheet and preformed shapes are intended for the augmentation or restoration of contour in craniofacial applications.

Device Story

MEDPOR® Plus Surgical Biomaterial is a composite implant material; formed by blending Bioglass® Synthetic Bone Graft Particulate with high-density polyethylene used in standard MEDPOR® implants. Device is provided in block, sheet, and preformed shapes. Used by surgeons in craniofacial procedures to augment or restore skeletal contour. Implant is placed surgically to provide structural support and contour correction.

Technological Characteristics

Composite material consisting of Bioglass® Synthetic Bone Graft Particulate blended with high-density polyethylene. Form factor includes blocks, sheets, and preformed shapes. Non-resorbable, biocompatible implant material.

Indications for Use

Indicated for patients requiring augmentation or restoration of contour in craniofacial applications.

Regulatory Classification

Identification

A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

Predicate Devices

• MEDPOR® Surgical Implant Material
• Bioglass® Synthetic Bone Graft Particulate

Submission Summary (Full Text)

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K012350

MAR 1 4 2002

Image /page/0/Picture/2 description: The image shows the logo for POREX Surgical Products Group. The word "POREX" is in large, bold, sans-serif font, with an arrow curving over the "O". Below the main logo, the words "SURGICAL PRODUCTS GROUP" are printed in a smaller, sans-serif font. The logo is black and white.

## 510(k) SUMMARY

Manufacturer and Submitter

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

Tel: [phone] Fax: [phone]

Contact: Howard Mercer, Ph.D. e-mail: [e-mail]

Date: October 10, 2001

Trade Name: MEDPOR® Plus Surgical Biomaterial Class II Device

Substantially equivalent to:

MEDPOR® Surgical Implant Material and to Bioglass® Synthetic Bone Graft Particulate

Device description:

The device of this submission is a material formed by blending Bioglass® Synthetic Bone Graft Particulate with the polyethylene used to produce MEDPOR® Surgical Implant Material.

Indications for Use:

MEDPOR® Plus Surgical Implants in block, sheet and preformed shapes are intended for the augmentation or restoration of contour in craniofacial applications.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them. The symbol is meant to represent health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2002

Howard Mercer, Ph.D. Manager of Operations and Regulatory Affairs Porex Surgical, Inc. 15 Dart Road Newnan, Georgia 30265

Re: K012350

Trade Name: Medpor Plus Surgical Implant Biomaterial Regulation Number: 878.3550 Regulation Name: Chin Implant Prosthesis Regulatory Class: II Product Code: FWP Dated: January 25, 2002 Received: January 28, 2002

Dear Dr. Mercer:

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 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 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.

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## Page 2 - Dr. Howard Mercer

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 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,

Miriam C. Provost
for Galia M. Witter, Ph.D., M.D.

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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012350

## INDICATION FOR USE

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

Tel: [phone] Fax: [phone]

K012350 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: MEDPOR® Plus Surgical Biomaterial

Indications for Use:

MEDPOR® Plus Surgical Implants in block, sheet and preformed shapes are intended for the augmentation or restoration of contour in craniofacial applications.

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**Prescription Use:** X
(Per 21CFR801.109

OR

Over the Counter Use:

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012350

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