MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT

K021357 · Porex Surgical, Inc. · HPZ · Aug 5, 2002 · Ophthalmic

Device Facts

• Record ID: K021357
• Device Name: MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
• Applicant: Porex Surgical, Inc.
• Product Code: HPZ · Ophthalmic
• Decision Date: Aug 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.

Device Story

MEDPOR Plus orbital volume replacement implants consist of high-density polyethylene blended with Bioglass Synthetic Bone Graft Particulate. These preformed implants are designed for surgical implantation to replace orbital volume. The device is used by surgeons in an operating room setting. By providing a biocompatible structure for tissue augmentation or restoration, the implant assists in reconstructing the craniofacial region, potentially improving aesthetic and functional outcomes for patients requiring orbital volume replacement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a composite of high-density polyethylene and Bioglass Synthetic Bone Graft Particulate. It is provided in various preformed shapes (spheres, conical implants, motility implants). The device is a non-active, implantable material.

Indications for Use

Indicated for patients requiring augmentation or restoration in the craniofacial region.

Regulatory Classification

Identification

An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Orbital volume replacement implants (pre-amendment)
• Bioglass Synthetic Bone Graft Particulate

Submission Summary (Full Text)

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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.

## 510(k) SUMMARY

Manufacturer and Submitter

K021357

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

Tel: [phone] Fax: [phone]

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

Date: April 26, 2002

Trade Name:

MEDPOR® Plus Sphere; MEDPOR® Plus COI™ (Conical Orbital Implant); MEDPOR® Plus MCOI™ (Multi-Purpose Conical Orbital Implant); MEDPOR® Plus SST™ Sphere (Smooth Surface Tunnel Sphere); MEDPOR®Plus SST™ COI™; MEDPOR®Plus MCOI™ SST™; MEDPOR® Plus QUAD™ Motility Implant

Class II Device

Substantially equivalent to:

Orbital volume replacement implants currently cleared for marketing and to Bioglass® Synthetic Bone Graft Particulate

Device description:

The devices of this submission are orbital volume replacement implants formed by blending @ Bioglass® Synthetic Bone Graft Particulate with the polyethylene used to produce MEDPOR Surqical Implant Material.

Indications for Use:

MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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## AUG 0 5 2002

Porex Surgical Inc. c/o Howard Mercer, Ph.D. Regulatory Affairs Manager 15 Dart Road Newnan, GA 30265

Re: K021357

Trade/Device Name: MEDPOR® Plus Orbital Volume Replacement Implant Regulation Number: 886.3320 Regulation Name: Eye sphere implant Regulatory Class: II Product Code: HPZ Dated: July 29, 2002 Received: July 30, 2002

Dear Dr. Mercer:

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- Howard Mercer, Ph.D.

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,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATION FOR USE

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

Tel: [phone] Fax: [phone]

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510(k) Number: K021357

Device Name: MEDPOR® Plus orbital volume replacement implants

MEDPOR® Plus Sphere; MEDPOR® Plus COI™ (Conical Orbital Implant); MEDPOR® Plus MCOI™ (Multi-Purpose Conical Orbital Implant); MEDPOR®Plus SST™ Sphere (Smooth Surface Tunnel Sphere); MEDPOR®Plus SST™ COI™; MEDPOR®Plus MCOI™ SST™; MEDPOR® Plus QUAD™ Motility Implant

Indications for Use:

MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.

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| (Division Sign-Off) | |
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| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K021357 |

| Prescription Use:<br>(Per 21CFR801.109 | OR | Over the Counter Use: |
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