POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE

K022665 · Hohenstein Enterprises, Inc. · KKY · Oct 9, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022665
• Device Name: POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE
• Applicant: Hohenstein Enterprises, Inc.
• Product Code: KKY · General, Plastic Surgery
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

Device Story

Porous HDPE Surgical Implants are pre-shaped, porous high-density polyethylene (HDPE) implants used for craniomaxillofacial skeletal augmentation or reconstruction. The device is provided in various forms, including blocks, sheets, and anatomical shapes. It is intended for surgical implantation by a physician. The porous structure of the material is designed to facilitate tissue integration. The device serves as a structural scaffold to restore or augment facial and cranial bone contours.

Clinical Evidence

No clinical data provided; substantial equivalence is based on material properties and historical clinical use of porous HDPE in craniofacial reconstruction.

Technological Characteristics

Material: Porous high-density polyethylene (HDPE). Form factor: Blocks, sheets, and anatomical shapes. Principle: Synthetic polymer implant for skeletal augmentation. Sterilization: Not specified.

Indications for Use

Indicated for augmentation or reconstruction of the craniomaxillofacial skeleton in patients requiring surgical intervention.

Regulatory Classification

Identification

A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

Predicate Devices

• Medpor® Surgical Implant Material; Preformed Cranial and Facial Implants (K922489)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

#### Porous HDPE Surgical Implants

# KO22665_

OCT 0 9 2002

ePor, Inc. 731 1/2 N. LaBrea Avenue Los Angeles, CA 90038 Tel: [phone], Fax: [phone]

#### CONTACT CONTACT CONTACT CONTACT

Eric V. Hohenstein Tel: [phone] Fax: [phone]

#### NAME OF DEVICE________________________________________________________________________________________________________________________________________________________________

Trade Name: Porous HDPE Surgical Implants, to be distributed under various trademarks including ePor, Biopor, Minopor, and p-HDPE.

Common Name: Preshaped porous polyethylene implants suitable for implantation into cranial and facial areas.

#### DEVICE CLASSIFICATION ________________________________________________________________________________________________________________________________________________________

| NOMENCLATURE | CLASS NO. | CLASS | REG NO. |
|--------------------------------------------|-----------|-------|----------|
| POLYMER ENT SYNTHETIC, POROUS POLYETHYLENE | 77JOF | II | 874.3620 |
| PROSTHESIS, CRANIOFACIIAL | 84JBA | II | 882.5330 |
| IMPLANT, MALAR | 79LZK | II | |
| PROSTHESIS, EYE, INTERNAL | 86FWO | II | 886.3200 |
| PROSTHESIS, FACIAL, MANDIBULAR IMPLANT | 77JAZ | II | 874.3695 |
| PROSTHESES/NASAL DORSAL IMPLANT | 79ESR | II | 878.3680 |
| PROSTHESIS, MAXILLA | 77JCS | II | |
| PROSTHESIS, MAXILLOFACIAL | 77LGK | | |
| PROSTHESIS, NOSE, NTERNAL | 79FZE | II | 878.3680 |
| PROSTHESIS, OTOPLASTY | 77ESY | II | 878.3590 |

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K022665 page 2/2

### STATEMENT OF SUBSTANTIAL EQUIVALENCE__________________________________________________________________________________________________________________________________________

ePor, Inc. Porous HDPE Surgical Implants are substantially equivalent to the Medpor® Surgical Implant Material; Preformed Cranial and Facial Implants K922489, based on the subject devices' similarity to the predicate devices in intended use, material, design, and surgical procedure.

#### INDICATIONS FOR USE

ePor, Inc. Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

#### DESCRIPTION __________________________________________________________________________________________________________________________________________________________________

ePor, Inc. Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are manufactured of porous high density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years.

Porous polyethylene is recognized as acceptable for implantation purposes through the folowing device classification per 21 Code of Federal Regulations.

| | CLASS NO. | CLASS | REG NO. |
|--------------------------------------------|-----------|-------|----------|
| POLYMER ENT SYNTHETIC, POROUS POLYETHYLENE | 77JOF | II | 874.3620 |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a wavy, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### 0 9 200

Mr. Eric Hohenstein ePor, Inc. 731 ½ N. LaBrea Avenue Los Angeles, California 90038

Re: K022665

> Trade/Device Name: Porous HDPE Surgical Implants Regulatory Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with Carbon Fibers Composite Implant Material

Regulatory Class: II Product Code: KKY Dated: August 6, 2002 Received: August 9, 2002

Dear Mr. Hohenstein:

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 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 - Mr. Eric Hohenstein

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,

Styph Rhodes

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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## STATEMENT OF INDICATIONS FOR USE

..

| APPLICANT: | ePor, Inc. |
|----------------------------|------------|
| 510(k) NUMBER: (if known): | K022665 |

DEVICE NAME: Porous HDPE Surgical Implants

#### INDICATIONS FOR USE:

Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) |
|----------------------|--------------------------------------------------------------|
| | Division of General, Restorative<br>and Neurological Devices |
| 510(k) Number | K022665 |
| | OR Over-The-Counter Use |
| Prescription Use | |
| (Per 21 CFR 801.109) | (Optional) |