MEDPOR CUSTOMIZED SURGICAL IMPLANT

K083621 · Porex Surgical, Inc. · JOF · Feb 3, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K083621
• Device Name: MEDPOR CUSTOMIZED SURGICAL IMPLANT
• Applicant: Porex Surgical, Inc.
• Product Code: JOF · Ear, Nose, Throat
• Decision Date: Feb 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

Device Story

MEDPOR Customized Surgical Implant is a patient-specific, porous high-density polyethylene (pHDPE) implant designed for craniofacial reconstruction. Input data includes CT scans, physical models, or physician-provided drawings/specifications. The device is manufactured to match patient-specific anatomy, allowing for integration with host tissues via porous matrix ingrowth. Used by surgeons in clinical settings; the implant is trimmable in the sterile field and compatible with standard plates and screws. It provides structural augmentation to restore bony contours, benefiting patients with craniofacial defects.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material similarity to legally marketed predicate devices.

Technological Characteristics

Material: porous high-density polyethylene (pHDPE). Sterilization: Ethylene Oxide (EO). Form factor: patient-specific custom shapes. Connectivity: None. Software: None. Mechanical: Trimmable in sterile field; compatible with plates and screws.

Indications for Use

Indicated for patients requiring augmentation or restoration of bony contour in craniofacial defects. Prescription use only.

Regulatory Classification

Identification

Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Predicate Devices

• MEDPOR Surgical Implant Material (K022480)
• Preformed Cranial & Facial Implants (K922489)

Submission Summary (Full Text)

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083621

Image /page/0/Picture/1 description: The image shows the logo for POREX Surgical Products Group. The word "POREX" is in large, bold, sans-serif font. Below the word "POREX" is the text "SURGICAL PRODUCTS GROUP" in a smaller, sans-serif font. The logo is black and white.

-3 2009

#### 510(k) SUMMARY

# Date of Summary: January 30, 2009

#### Manufacturer and Submitter:

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

Tel: [phone] Fax: [phone]

Contact: Mrs. Jerri Mann E-mail: [e-mail]

Trade Name: MEDPOR® Customized Surgical Implant

Class: II 21 CFR 874.3620 Ear, nose, and throat synthetic polymer material.

Product Code: JOF

Subsequent Product Code: GWO

Substantially equivalent to: MEDPOR Surgical Implant Material; Preformed Cranial &
Facial Implants, K022480 Facial Implants, K922489

#### Device Description:

MEDPOR Customized Surgical Implants. are prescription devices tailored to a patient's same hiocompatible nure nown his his mized Surgical Implants are made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as all MEDPOR Surgical Implants. An advantage of (pHDPE) is that the surrounding body tissue grows into the porous matrix, so the implant becomes integrated with and stabilized in the host tissues.

### Indications for Use:

The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

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Image /page/1/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 text "SURGICAL PRODUCTS GROUP" in smaller, thinner letters. The logo is simple and professional.

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# Technological Characteristics:

MEDPOR Customized Surgical Implant shapes can be created from CT scan data, a physical model, drawing or other information provided by a physician. MEDPOR Customized Surgical Implant shapes have the same intended use, are manufactured from the same material, can be trimmed with a blace in the sterile field, will accept plates and screws and are packaged the same as other MEDPOR Preformed Cranial and Facial Implants. MEDPOR Customized Surgical Implants are sterilized with Ethylene Oxide.

## Substantial Equivalence:

MEDPOR Customized Surgical Implans are substantially equivalent to the predicate device MEDPOR Surgical Implant Material; Preformed Cranial & Facial Implans. The comparison table below details the similarities between MEDPOR Customized Surgical Implants and the predicate device:

| Characteristic | MEDPOR Surgical Implant | MEDPOR Customized<br>Surgical Implant | SE<br>Y/N |
|----------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------|
| Intended Use | For augmentation or restoration of bony<br>contour in craniofacial defects. | For augmentation or restoration of bony<br>contour in craniofacial defects. | Y |
| Materials | A linear, high-density polyethylene<br>biomaterial | A linear, high-density polyethylene<br>biomaterial | Y |
| Manufacturing Process | Preformed Shapes | Patient Specific Preformed Shapes | Y |
| Size Ranges/Specifications | Refer to Product Catalog | Customized according to a signed<br>prescription form | Y |
| Shapes | Refer to Product Catalog | Customized according to a signed<br>prescription form | Y |
| Packaging | Double peel pouched and put in a<br>Clamshell or shelf box | Double peel pouched and put in a<br>Clamshell or shelf box | Y |
| Sterile/Non-Sterile | Sterile | Sterile | Y |
| Sterilization Method | EO Gas | EO Gas | Y |
| Non-Pyrogenic Claim | YES | NO | N |

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| Shelf-Life | 10 years | 10 years | Y |
|---------------------|--------------------------------------------------------------------------------------|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Yes | Yes | Y |
| Prescription Device | Yes - Sale by or on the order of a physician | Yes - Sale by or on the order of a physician | Y |
| Labeling | MEDPOR Surgical Implants including TITAN!™ and BARRIER™ Implant Instructions For Use | MEDPOR CUSTOMIZED Surgical Implants | Y - Different only in that the labeling removes NON-PYROGENIC claim and has the statement "not tested for endotoxin". |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Porex Surgical, Inc. c/o Jerri L. Mann Regulatory Compliance Manager 15 Dart Road Newman. GA 30265-1017

FEB - 3 2009

Re: K083621

Trade/Device Name: MEDPOR® Customized Surgical Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: JOF, GWO Dated: December 3, 2008 Received: December 16, 2008

Dear Ms. Mann:

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. Iisting 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

M.B. Epolins, mD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K083621

# Indications for Use

510(k) Number (if known):

Device Name: MEDPOR® Customized Surgical Implant

Indications for Use: The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Page

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amaloui

(Division Sign-Off) (Division Sign-Off)
Division of Ophthalmic and Ear,
Throat Throat Devices Division of Ophicial
Nose and Throat Devices

Nose and
510(k) Number k08362