BONALIVE GRANULES AND BONALIVE PLATES

K071937 · Vivoxid , Ltd. · KKY · Oct 19, 2007 · General, Plastic Surgery

Device Facts

Record IDK071937
Device NameBONALIVE GRANULES AND BONALIVE PLATES
ApplicantVivoxid , Ltd.
Product CodeKKY · General, Plastic Surgery
Decision DateOct 19, 2007
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.3500
Device ClassClass 2
AttributesTherapeutic

Intended Use

BonAlive™ Granules and BonAlive™ Plate are intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton.

Device Story

BonAlive™ Granules and Plates are synthetic, osteoconductive, and bacterial growth-inhibiting bone grafting materials composed of S53P4 bioactive glass (SiO2 53%, Na2O 23%, CaO 20%, P2O5 4%). The device is used by surgeons to fill, augment, or reconstruct bony defects in the cranio-maxillofacial region. Upon implantation, a silica-gel layer forms on the glass surface, acting as a template for calcium phosphate precipitation, which chemically bonds the material to surrounding bone. This process guides tissue growth and promotes new bone formation. The material is supplied in various granule and plate sizes and is sterilized via hot dry air. Clinical benefits include stable, well-tolerated bone filling and closure of defects, such as in frontal sinus obliteration, orbital floor fractures, and nasal cavity procedures.

Clinical Evidence

Evidence includes preclinical biocompatibility, solubility, and surface structure testing. Animal studies showed BAG produced more and faster new bone compared to hydroxyl apatite controls. Human clinical studies in frontal sinus obliteration, orbital floor fractures, and nasal cavity procedures demonstrated the material is stable, well-tolerated, and effective for permanent filling. Healing and stability were assessed via ROI assessments. No harmful reactions were reported during clinical follow-up.

Technological Characteristics

Material: S53P4 bioactive glass (SiO2 53%, Na2O 23%, CaO 20%, P2O5 4%). Form: Granules and plates. Principle: Osteoconductive, chemical bonding via silica-gel layer and calcium phosphate precipitation. Sterilization: Hot dry air. Connectivity: None (standalone).

Indications for Use

Indicated for the augmentation or reconstruction of the cranio-maxillofacial skeleton in patients requiring bone grafting for defects or damaged bony tissue.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "Vivoxid" in a stylized font. The letters are in black, with the first three letters being solid and the last four letters having a textured, almost pixelated appearance. The font appears to be a serif font. # 510(k) Summary CCT 1 9 2007 Submitter: Vivoxid Ltd. Turku, Finland Contact Information: Constance G. Bundy C. G. Bundy Associates, Inc. 6470 Riverview Terrace Fridley, MN 55432 Submission Date: July 10, 2007 Device Name and Classification: BonAlive™ Granules and Plates Image /page/0/Figure/8 description: The image shows the text "Product Code: KKY" and "Class II per 21 CFR 878.3500". The text is black and is on a white background. The image is a close-up of the text. ### Equivalent Device Identification: Porous HDPE Surgical Implants, K022665 PerioGlas® Bone Graft Particulate, 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 guide tissue growth, bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. 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 and bacterialgrowth inhibiting material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P>O5 4%. BonAlive™ products are supplied as granules and plates. Both are bone grafting materials intended to fill, augment, or reconstruct bony defects of the cranial and maxillofacial region. BonAlive™ granules and plates are sterilized in hot dry air. The granules are available as different granule and unit sizes. The plates are available in different shapes and sizes. Intended Use: BonAlive™ Granules and BonAlive™ Plate are intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton. Vivoxid Ltd. Turku, Finland {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "Vivoxid" in a stylized font. The first two letters, "Vi", are in a clear, bold font, while the rest of the letters appear to be textured or slightly blurred. The word is presented in a simple, straightforward manner against a plain background. ### Comparison Table: | Descriptive<br>Information | BonAlive™ granules and<br>plates | Porous HDPE<br>Surgical<br>Implants, K022665 | PerioGlas Bone<br>Graft Particulate,<br>K053387 | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | Intended Use | BonAlive™ Granules and<br>BonAlive™ Plate are<br>intended for the<br>augmentation or<br>reconstruction of the cranio-<br>maxillofacial skeleton. | Porous HDPE<br>Surgical Implants<br>are intended<br>for the augmentation<br>or reconstruction<br>of the cranio-<br>maxillofacial areas. | Same as BonAlive<br>device | | Material and<br>properties | S53P4 Bioactive Glass -<br>synthetic, osteoconductive,<br>bacterial growth inhibiting | Alloplastic, porous<br>high density<br>polyethylene<br>(HDPE) | 45S5 Bioactive<br>Glass - same<br>properties as<br>BonAlive | | Product Form | Granules and plates | Block, sheet,<br>anatomical shapes | Particulates | | Mode of Action | Tissue bonds to the<br>bioactive glass due to the<br>formation of a silica-gel<br>layer on the glass. The<br>silica-rich layer acts as a<br>template for a calcium<br>phosphate precipitation,<br>which bonds the bioactive<br>glass to the surrounding<br>bone. | The porous HDPE<br>allows for bony<br>tissue ingrowth into<br>its pores | Same as BonAlive<br>device | | Resorption Rate | Slowly, over a period of<br>years | Not applicable | Six months | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | | Sterilization Method | Hot dry air | Sterile | EtO | K071937 # Summary of Perfomance Testing of Bioactive Glass (BAG) S53P4, BonAlive™: Preclinical testing included biocompatibility, solubility, surface structure and dissolution. The amounts of Si and P released from BAG were extremely low indicating a good stability and safety of this material for clinical use in frontal sinus obliteration gThe amount of calcium (Ca) released from the material seems to create a suitable environment for formation of calcium phosphate layer that is prerequisite for new bone formation. The biocompatibility tests showed the device was safe for the intended uses. In animal studies BAG produced more and faster new bone than did the hydroxyl apatite that was used as a control. Proper blood circulation in the periosted in flap at early stage predisposed the healing process with both materials. The healing process proceeded after the connective tissue phase to obliteration of bone cavity both in animal and in human clinical studies. {2}------------------------------------------------ # VivoxID Clinically BAG is well functioning, stable, safe and well tolerated glass material that creates suitable local environment for permanent filling of frontal sinuses. Remnants of glass particles found in the bony filling seem to maintain the achieved bone formation and closure of sinuses. The healing process and stability of the clinical outcome in sinuses could be assessed reliably by using the ROI assessments. K071937 In patients with orbital floor fractures the orbital floor prostheses manufactured from BAG have been well functioning and well tolerated. The same conclusion can be made on the use of BAG in septum perforations and narrowing of the nasal cavity. The material itself has not caused any harmful reactions during the clinical follow-up period. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Vivoxid Ltd. % C.G. Bundy Associates, Inc. Ms. Constance G. Bundy 6470 Riverview Terrace Fridley, Minnesota 55432 OCT 1 9 2007 Re: K071937 Trade/Device Name: BonAlive™ Granules and BonAlive™ Plates Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KKY Dated: October 1, 2007 Received: October 4, 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. 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 {4}------------------------------------------------ Page 2 - Ms. Constance G. Bundy 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 (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obhain, other general information on your responsibilities under the Act from the Division of a mall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html Sincerely your Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Vivoxic ## Indications for Use 510(k) Number (if known): K071937 Device Name: BonAlive™ Granules and BonAlive™ Plates Indications for Use: BonAlive™ Granules and BonAlive™ Plate are intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ ...... ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 (Division Sign-Off) Division of General, Restorative, and Neurological Devices 11071937 510(k) Number Vivoxid Ltd. Turku, Finland
Innolitics
510(k) Summary
Decision Summary
Classification Order
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