MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH by POREX SURGICAL, INC.

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 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.

AI/ML Overview

The provided text is a 510(k) summary for the MEDPOR Craniofacial Implants with Embedded Titanium Mesh. This document focuses on establishing substantial equivalence to previously marketed predicate devices, rather than detailed performance studies against specific acceptance criteria. Therefore, the document does not contain the requested information about acceptance criteria, device performance, validation study details, or AI-related metrics.

Specifically, the document includes:

Device Description: A description of the implant configurations (titanium mesh encapsulated in various MEDPOR biomaterials).
Indications for Use: Non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.
Predicate Devices: A list of devices to which the new device is considered substantially equivalent.

The document does NOT provide:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Information on experts used to establish ground truth or adjudication methods.
Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance.
Information about standalone algorithm performance.
The type of ground truth used in any study.
Sample size for a training set.
How ground truth for a training set was established.

This is typical for 510(k) summaries which primarily aim to demonstrate substantial equivalence based on existing predicate device performance and material characteristics, rather than new comprehensive clinical or engineering validation studies against predefined acceptance criteria for novel performance claims.

Summary

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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: (678) 479-1610 Fax: (678) 423-1437

Contact: Greg Swords e-mail: greg.swords@porex.com

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:

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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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: (678) 479-1610 Fax: (678) 423-1437

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:

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.