FORTOSS VITAL

K082383 · Biocomposites, Ltd. · LYC · Sep 5, 2008 · Dental

Device Facts

• Record ID: K082383
• Device Name: FORTOSS VITAL
• Applicant: Biocomposites, Ltd.
• Product Code: LYC · Dental
• Decision Date: Sep 5, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of Fortoss® Vital is for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.

Device Story

Fortoss® Vital is a synthetic bone graft substitute consisting of a calcium salt-based powder and liquid component. Components are mixed intraoperatively by a clinician to create a homogeneous, mouldable paste. The paste is applied to osseous defects in periodontal, maxillofacial, or dental implant sites. Upon contact with viable host bone, the material acts as a scaffold; new bone grows in apposition to the implant surface, filling pores during the healing process. The material is resorbable, gradually replaced by natural bone. The device is provided sterile for single-patient use.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Synthetic bone graft substitute; calcium salt-based powder and liquid components; mouldable paste form factor; resorbable; sterile; single-patient use.

Indications for Use

Indicated for patients requiring bone grafting in periodontal, maxillofacial, and dental implant surgery to fill osseous defects.

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

• Fortoss® Vital (K052303)

Submission Summary (Full Text)

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## 510(k) SUMMARY

SEP - 5 2008

# Fortoss® Vital

Applicant Biocomposites Ltd Keele Science Park Keele Staffordshire England ST5 ENT

Contact Person Miss Marie Whallev [phone] Tel: Fax [phone] Email: [e-mail]

Classification Name: Common/Usual Name: Trade/Proprietary Name Product Code

Bone grafting material, synthetic Synthetic Bone Graft Substitute Fortoss® Vital LYC

## Device Description

Fortoss® Vital bone graft substitute is a calcium salt based pre-measured powder and liquid component. The two components are designed to be mixed intraoperatively to produce a homogeneous paste which can then be applied to osseous defects.

The product is provided sterile for single patient use. When Fortoss® Vital is placed in direct contact with viable host bone, new bone grows in apposition to the surface of the implant, filling the pores with new bone during the healing process. As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute.

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### Intended Use / Indications

The intended use of Fortoss® Vital is for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.

## Summary of Technology

The modified Fortoss® Vital has the same technological characteristics as the predicate device and any differences do not raise any concerns regarding safety and effectiveness.

The modified Fortoss® Vital provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The indications, contraindications, risks and potential adverse events are the same as the identified predicate device and are thus substantially equivalent.

### Non Clinical Testing

Data supplied demonstrates that the modified Fortoss® Vital is substantially equivalent to the predicate device and any differences do not raise any concerns regarding safety and effectiveness.

## Substantial Equivalence

Documentation provided demonstrates that the modified Fortoss® Vital is substantially equivalent to the legally marketed predicate device in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of the modified device.

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Image /page/2/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 eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marie Whalley Biocomposites, Limited Keele Science Park Keele Staffordshire England ST5 5NL

SEP - 5 2008

Re: K082383

Trade/Device Name: Fortoss Vital Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 14, 2008 Received: August 19, 2008

Dear Ms. Whalley:

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. Whalley

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 on use not 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 pregative 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, parmits 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 Center for Devices and Radiological Health's (CDR ('s' S) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other geaderal 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.

JKAmelia-Lend on D for 11

Chiu S. Lin, Ph. D Division 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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# INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Fortoss® Vital

Indications For Use:

Fortoss® Vital is intended for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.

V Prescription Use (Part 21 CFR 801 Subpart D)

OR

No Over-The-Counter use (Part 21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

510(k) Number: K052303

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