CYTOFLEX MESH

K021511 · Unicare Biomedical, Inc. · JEY · Aug 6, 2002 · Dental

Device Facts

• Record ID: K021511
• Device Name: CYTOFLEX MESH
• Applicant: Unicare Biomedical, Inc.
• Product Code: JEY · Dental
• Decision Date: Aug 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate augmentation with adequate fixation of the augmentation material.

Device Story

Cytoflex Mesh is a precision titanium mesh used in dental/oral surgery for alveolar bone reconstruction. Device provides structural support to maintain space for bone regeneration and facilitates fixation of grafting materials. Supplied in various sizes and thicknesses in sealed pouches. Used by clinicians in surgical settings to stabilize bone graft sites. By maintaining the shape of the defect and securing the graft, the mesh supports predictable bone augmentation, potentially improving clinical outcomes for patients requiring dental implants or reconstructive procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Precision titanium mesh; specific dimensions and pore sizes; biocompatible material; supplied sterile in sealed pouches.

Indications for Use

Indicated for patients requiring three-dimensional reconstruction of alveolar bone defects and augmentation of bone, facilitating fixation of augmentation material.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• Precision Titanium Foil (Imtec Corporation)
• Osteomed MSS (Osteomed Corporation)
• Micro-Titanium Augmentation Mesh (Howmedica-Leibinger)
• Ti Mini Bone Plate and Screws (Walter Lorenz Surgical, Inc.)
• Reconstructive Surgery System (Ti Mesh Inc.)
• Osteogenics Cytoplast GBR (Osteogenics Corporation)
• Imtec BioBarrier membrane (Imtec Corporation)
• Gore-tex Regenerative Material (W.L. Gore & Associates, Inc.)

Submission Summary (Full Text)

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K021511

510(K) Summary (As Required by Section 807.92 (c))

- 1. Submitter

| Name: | Unicare Biomedical |
|----------|------------------------------------------------|
| Address: | 25951 La Cuesta Avenue, Laguna Hills, CA 92653 |
| Contact: | Stan Yang, 949-643-6707 |
| Date: | February 20, 2002 |

- 2. Device Name

| Trade Name: | Cytoflex Mesh |
|------------------------|----------------------------------------------------------|
| Common Name: | Precision Titanium Mesh |
| Classification Name: | Implant, Endosseous for bone filling and/or augmentation |
| Device Classification: | Unclassified |

## 3. Predicate Devices

Precision Titanium Foil (Imtec Corporation) Osteomed MSS (Osteomed Corporation) Micro-Titanium Augmentation Mesh (Howmedica-Leibinger) Ti Mini Bone Plate and Screws (Walter Lorenz Surgical, Inc.) Reconstructive Surgery System (Ti Mesh Inc.) Osteogenics Cytoplast GBR (Osteogenics Corporation) Imtec BioBarrier membrane (Imtec Corporation) Gore-tex Regenerative Material (W.L. Gore & Associates, Inc.)

- 4. Device Description
Cytoflex Mesh is a precision titanium mesh of a specific dimension and pore size. Cytoflex Mesh is supplied in specific sizes and thickness in sealed pouches. Cytoflex Mesh is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.

- 5. Indication
Cytoflex Mesh is indicated for use in ensuring three-dimensional reconstruction of alveolar bone defects and for facilitating augmentation with adequate fixation of the augmentation material.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

AUG 0 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stan Yang, Ph.D. Vice President of Operations Unicare Biomedical, Incorporated 25951 La Cuesta Avenue Laguna Hills, California 92653

Re: K021511

> Trade/Device Name: Cytoflex Mesh Regulation Number: 21 CFR 872.4760 Regulation Name: Precision Titanium Mesh Regulatory Class: II Product Code: JEY Dated: May 3, 2002 Received: May 9, 2002

Dear Dr. Yang:

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 - Dr. Yang

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.qov/cdrh/dsmamain.html

Sincerely,

Timothy A. Ulatowski

Directør Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (K) NUMBER (IF KNOWN): DEVICE NAME: CYTOFLEX™ MESH INDICATIONS FOR USE:

For use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate augmentation with adequate fixation of the augmentation material.

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

or

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription of Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional format 1-2-96)

Susan Runn

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: k021511