IMMIX BONE GRAFT EXTENDER

K013764 · Osteogenics Biomedical, Inc. · KKY · May 16, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013764
• Device Name: IMMIX BONE GRAFT EXTENDER
• Applicant: Osteogenics Biomedical, Inc.
• Product Code: KKY · General, Plastic Surgery
• Decision Date: May 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

As a spacemaking device used in cranio-facial guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation. Not to be used in load-bearing areas.

Device Story

Immix is a DL-polylactide resorbable polymer material designed as a spacemaking device for guided bone regeneration. It is used in cranio-facial procedures to treat bony defects, maintain ridges, preserve alveolar sockets, or perform ridge augmentation. The device is supplied sterile and can be used alone or combined with other materials to create space for bone regeneration. It is intended for prescription use by clinicians. The device is not for use in load-bearing areas.

Clinical Evidence

Bench testing and biocompatibility testing only; no clinical data provided.

Technological Characteristics

Material: DL-polylactide resorbable polymer. Form factor: Spacemaking device. Sterilization: Supplied sterile.

Indications for Use

Indicated for patients requiring cranio-facial guided bone regeneration for treatment of bony defects, ridge maintenance, alveolar socket preservation, or ridge augmentation. Contraindicated for use in load-bearing areas.

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

• HTR Polymer, U. S. Surgical (K904111)

Submission Summary (Full Text)

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K013764

# 510 (k) SUMMARY

#### l. ADMINISTRATIVE

Osteogenics Biomedical, Inc. Submitter: 3234 - 64th Street Lubbock, Texas 79413 [phone]

Contact Person: Chad Bartee

Date of Preparation: November 12, 2001

#### DEVICE NAME II.

Proprietary Name: Immix ™ Common Name: Bone Graft Extender Classification Name: Material, Polytetrafluoroethylene Vitreous Carbon for Maxillofacial Reconstruction

#### PREDICATE DEVICE .

HTR Polymer, U. S. Surgical (K904111)

### IV. DEVICE DESCRIPTION

Immix™ is a DL-polylactide resorbable polymer material intended for use by itself or in combination with other materials to create space for bone regeneration. The material is packaged individually in various amounts and supplied sterile.

#### V. INTENDED USE

As a spacemaking device used in guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation.

#### COMPARISON TO PREDICATE DEVICE vi.

The Immix™ polymer material is similar in composition, and identical in function and intended use to legally marketed devices such as HTR Polymer, U. S. Surgical.

The results of performance and biocompatibility testing show that the Immix™ polymer material is safe and effective for its intended use and performs at least as well as legally marketed predicate devices, such as the HTR Polymer material.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# 16 2002

Osteogenics BioMedical, Incorporated C/O Richard A. Hamer Richard Hamer Associates, Incorporated 6401 Meadows West Drive Fort Worth, Texas 76132

Re: K013764

Trade/Device Name: Immix Bone Graft Extender Regulation Number: 878.3500 Regulation Name: Polytetrafluoroethylene with Carbon Fibers Composite Implant Material Regulatory Class: Unclassified Product Code: LYC and KKY Dated: February 21, 2001 Received: February 25, 2002

### Dear Mr. Hamer:

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.

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## Page 2 - Mr. Hamer

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.

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,

Patricia Cicconte/foe

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

K013764

Device Name: Immix™ Bone Graft Extender

Indications for Use:

As a spacemaking device used in cranio-facial guided bone regeneration. Treatment of bony defects, ridge maintenance, alveolar socket preservation or ridge augmentation. Not to be used in load-bearing areas.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use _ OR

Swoon Rogers

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number - ( 0 ) 3