BONALIVE GRANULES AND BONALIVE PLATES

K070055 · Vivoxid , Ltd. · LYC · Jun 25, 2007 · Dental

Device Facts

• Record ID: K070055
• Device Name: BONALIVE GRANULES AND BONALIVE PLATES
• Applicant: Vivoxid , Ltd.
• Product Code: LYC · Dental
• Decision Date: Jun 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BonAlive™ Granules are sterile medical devices consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct periodontal or bony defects. BonAlive™ Granules are indicated for use in the craniomaxillofacial area including jaws.

Device Story

BonAlive™ Granules are sterile, synthetic, osteoconductive bone grafting material composed of S53P4 bioactive glass (SiO2 53%, Na2O 23%, CaO 20%, P2O5 4%). Intended for use in oral and maxillofacial surgery to fill, augment, or reconstruct bony defects. Principle of operation involves physico-chemical bonding to living tissue; silica-gel layer forms on glass surface upon implantation, acting as a template for calcium phosphate precipitation, facilitating integration with bone matrix. Supplied as granules of varying sizes; sterilized via hot dry air. Used by clinicians in surgical settings to promote new bone formation in implantation beds.

Clinical Evidence

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

Technological Characteristics

Material: S53P4 bioactive glass (SiO2 53%, Na2O 23%, CaO 20%, P2O5 4%). Form factor: Granules of varying sizes. Principle: Osteoconductive, physico-chemical bone bonding. Sterilization: Hot dry air. No software or electronic components.

Indications for Use

Indicated for filling, augmenting, or reconstructing periodontal or bony defects in the craniomaxillofacial area, including the jaws.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• NovaBone Perioglas® (K053387)
• NovaBone-C/M® (K053387)

Submission Summary (Full Text)

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K070055

Vivoxid Ltd. Turku, Finland

5. 510(k) Summary

Submitter: Vivoxid Ltd. Turku, Finland

Contact Information: Constance G. Bundy C. G. Bundy Associates, Inc. 6470 Riverview Terrace Fridley, MN 55432

Submission Date: December 29, 2006

Device Name and Classification: BonAlive™ Granules Bone Grafting Material, Product Code: LYC Class II per 872.3930

## Equivalent Device Identification: NovaBone Perioglas®, NovaBone-C/M®, K053387

Device Description: BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. Bone bonding is a physico-chemical process leading to continuity between an implant and bone matrix. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P2O5 4%.

BonAlive™ products are supplied as granules are bone grafting materials intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. BonAlive™ granules are sterilized in hot dry air. The granules are available as different granule and unit sizes.

Intended Use: BonAlive™ granules consist of bioactive glass, a bone grafting material that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillo facial region.

JUN 2 5 2007

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2007

Vivoxid Limited C/O Ms. Constance G. Bundy C.G. Bundy Associates, Incorporated 6470 Riverview Terrace Fridley, Minnesota 55432

Re: K070055

Trade/Device Name: BonAlive™ Granules Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: June 15, 2007 Received: June 19, 2007

Dear Ms. Bundy:

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 - Ms. Bundy

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Suste Y. Michaid md.

Chiu Lin, Ph.D. Director 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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K070055

## 4. Indications for Use

510(k) Number (if known): K070055

Device Name: BonAlive™ Granules

Indications for Use:

BonAlive™ Granules are sterile medical devices consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct periodontal or bony defects. BonAlive™ Granules are indicated for use in the craniomaxillofacial area including jaws.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Susan Penner

Sion Sign-Off) Chision of Anesthesiology, General Hospital, Infaction Control, Dental Devices

510(K) Number: k070055