ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE

K090850 · Apatech , Ltd. · LYC · Jul 30, 2009 · Dental

Device Facts

• Record ID: K090850
• Device Name: ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
• Applicant: Apatech , Ltd.
• Product Code: LYC · Dental
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Actifuse is a synthetic bone grafting material intended to fill, augment, and/or reconstruct maxillofacial osseous bone defects including periodontal, oral and craniomaxillofacial applications. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a synthetic bone grafting material that resorbs and is replaced by bone during the healing process.

Device Story

Actifuse is a bioactive, synthetic, silicon-substituted calcium phosphate bone graft substitute; porous scaffold structure mimics human cancellous bone. Used by surgeons to fill, augment, or reconstruct maxillofacial osseous defects from surgery or trauma. Material resorbs over time, replaced by natural bone during healing. Bioactive properties (0.8wt% silicate) accelerate apatite layer formation and cellular metabolic activity/proliferation compared to non-silicated calcium phosphate. Device serves as osteoconductive/osteostimulatory scaffold for bony infiltration and repair. No clinical data provided; safety/efficacy supported by bench and in-vitro studies.

Clinical Evidence

No clinical data. Evidence consists of bench testing and in-vitro studies. In-vitro studies showed 29% faster apatite layer formation and accelerated cellular metabolic activity/proliferation compared to non-silicated calcium phosphate controls. Bench testing confirmed compliance with relevant standards for bone graft substitutes.

Technological Characteristics

Bioactive phase-pure silicon-substituted calcium phosphate; porous scaffold (granules or granules in resorbable polymer matrix). Interconnected open porous structure. Osteoconductive and osteostimulatory. Non-mechanical/non-electronic; no energy source. Sterilized.

Indications for Use

Indicated for filling, augmenting, or reconstructing maxillofacial osseous defects (periodontal, oral, craniomaxillofacial) resulting from surgery or trauma in patients requiring bone grafting.

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

• Actifuse family of bone graft substitutes (K040082, K071206, K080736, K082073, K081979, K082575)
• Biomatlante MBCP (K060732, K051885)

Submission Summary (Full Text)

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K090850

'JUL 3 0 2009

# Premarket Notification [510(K)] Summary

(per 21 CFR 807.92)

#### Submitter:

. . .

ApaTech Limited 370 Centennial Avenue Elstree, Hertfordshire WD6 3TJ United Kingdom

Contact Person:

Regina Cassidy Director, Regulatory Affairs 2 Hampshire Street Foxboro, MA 02035 508-543-0700 (phone) ·508-543-5551 (fax)

Date Prepared:

### July 20, 2009

Classification:

Bone grafting material devices have been classified by the Dental Device Panel as Class II Special Controls per 21 CFR 872.3930, Product Code LYC.

Trade Name:

Actifuse™ Bone Graft Substitute Actifuse™ Microgranules Bone Graft Substitute Actifuse™ E-Z-Prep Actifuse™ ABX Bone Graft Substitute Actifuse™ MIS Actifuse™ Shape Bone Graft Substitute Actifuse™ Flow Bone Graft Substitute

Common Name:

Bone Graft Substitute

Predicate Devices:

Actifuse™ family of bone graft substitutes, K040082, K071206, K080736, K082073, K081979, K082575

Biomatlante MBCP, K060732, K051885

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#### Intended use:

Actifuse is a synthetic bone grafting material intended to fill, augment, and/or reconstruct maxillofacial osseous bone defects including periodontal, oral and craniomaxillofacial applications. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a synthetic bone grafting material that resorbs and is replaced by bone during the healing process.

#### Device Description

Products in the Actifuse™ family are bioactive phase-pure silicon-substituted calcium phosphate osteoconductive bone graft substitutes, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the calcium phosphate phase of Actifuse is similar to human cancellous bone.

#### Technological Characteristics and Substantial Equivalence

Actifuse products are composed of a porous calcium phosphate, equivalent to that contained in both predicate devices and to that in routine clinical use. The technologies employed in Actifuse and its predicate devices are therefore substantially equivalent. Actifuse products have the same indications, contraindications, risks and potential adverse events as the predicate devices, and thus substantial equivalence is claimed for the device.

#### Testing

Bench testing has shown Actifuse™ family of devices to meet the requirements of all relevant standards for bone graft substitutes. Testing has confirmed Actifuse products to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold.

Actifuse is bioactive based on in-vitro studies in which growth of an apatite layer was induced on the surface of Actifuse following exposure to simulated body fluid. The time required to form a new apatite layer on the surface of Actifuse was reduced by 29% when compared to an identical calcium phosphate material that did not contain 0.8wt% silicate.

Actifuse is found to be osteostimulatory based on cell culture studies that showed that cellular responses, such as metabolic activity and proliferation, were accelerated when compared to an identical material that did not contain 0.8wt% silicate.

These results demonstrate that Actifuse is an active scaffold supporting rapid bone formation. The bioactive and osteostimulatory nature of Actifuse has not been correlated with human clinical experience.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Regina Cassidy Director of Regulatory Affairs Apa Tech Limited 2 Hampshire Street Foxboro, Massachusett 02035

## JUL 3 0 2009

Re: K090850

Trade/Device Name: Actifuse™ Bone Graft Substitute

Actifuse™ Microgranules Bone Graft Substitute

Actifuse™ E-Z-Prep

Actifuse™ ABX Bone Graft Substitute

Actifuse™ MIS

Actifuse™ Shape Bone Graft Substitute Actifuse™ Flow Bone Graft Substitute

Regulation Number: 21 CFR 872.3930

Regulation Name: Bone Grafting Material

Regulatory Class: II

Product Code: LYC

Dated: July 20, 2009

Received: July 22, 2009

Dear Ms. Cassidy:

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 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. Cassidy

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 Pari 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Susan Rusne

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K090850

### Statement of Indications for Use

510(k) Number (if known): K090850

Device Name:

Actifuse™ Bone Graft Substitute

Actifuse™ Microgranules Bone Graft Substitute

Actifuse™ E-Z-Prep

Actifuse™ ABX Bone Graft Substitute

Actifuse™ MIS

Actifuse™ Shape Bone Graft Substitute

Actifuse™ Flow Bone Graft Substitute

Indications for Use:

Actifuse is a synthetic bone grafting material intended to fill, augment, and/or reconstruct maxillofacial osseous bone defects including periodontal, oral and craniomaxillofacial applications. These defects may be surgically created osseous defects or ossequs defects created from traumatic injury to the bone. The product provides a synthetic bone grafting material that resorbs and is replaced by bone during the healing process.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Suen

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

510 (k) Number