FORTOSS VITAL BONE GRAFT SUBSTITUTE

K050170 · Biocomposites, Ltd. · LYC · Aug 26, 2005 · Dental

Device Facts

• Record ID: K050170
• Device Name: FORTOSS VITAL BONE GRAFT SUBSTITUTE
• Applicant: Biocomposites, Ltd.
• Product Code: LYC · Dental
• Decision Date: Aug 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fortoss Vital™ is indicated 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, resorbable, calcium phosphate-based bone graft substitute. Provided as granules or powder, it is placed into osseous defects by clinicians during periodontal, maxillofacial, or dental implant procedures. The material acts as a scaffold, allowing new bone to grow in apposition to the implant while the graft is gradually resorbed and replaced by natural bone during the healing process. It is intended for use by dental and surgical professionals in clinical settings.

Clinical Evidence

No clinical trials were conducted for this submission. The manufacturer states the device has been regularly used clinically with no reported adverse events concerning quality, safety, or effectiveness. Evidence is based on non-clinical bench testing of chemical composition and comparison to predicate devices.

Technological Characteristics

Porous calcium phosphate-based bone graft substitute. Provided as granules or powder. Sterile, single-patient use. Resorbable. No energy source or software components.

Indications for Use

Indicated for patients requiring bone graft substitutes 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

• Straumann Granules (Bone Graft Substitute) (K040646)
• Hapset (Bone Graft Material) (K910432)

Submission Summary (Full Text)

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K 050170

AUG 2 6 2005

# EXHIBIT 12

## 510(k) SUMMARY

### Fortoss Vital™

Applicant Biocomposites Ltd Keele Science Park Keele Staffordshire England ST5 5NL

| Contact Person | | Mr Simon Fitzer |
|----------------|-----|-----------------------------|
| | | Tel: [phone] |
| | Fax | [phone] |
| | | Email: [e-mail] |

| 1. | Classification Name: | Synthetic Bone Graft Material |
|----|------------------------|----------------------------------------|
| | Common/Usual Name: | Synthetic Bone Graft Substitute |
| | Trade/Proprietary Name | Fortoss Vital™ - Bone Graft Substitute |
| | Product Code | LYC |

#### Legally Marketed Predicate Devices

| | Trade Name | Manufacturer | 510(k) No |
|---|--------------------------------------------|-------------------------|-----------|
| 1 | Straumann Granules (Bone Graft Substitute) | Straumann AG | K040646 |
| 2 | Hapset (Bone Graft Material) | Lifecore Biomedical Inc | K910432 |

#### Device Description

Fortoss Vital™ Bone Graft Substitute is a calcium phosphate based bone graft substitute and is provided sterile for single patient use. When Fortoss Vital™ is placed in the defect, bone grows in apposition to the implant, filling the pores with new bone during the healing process.

Fortoss Vital™ is completely resorbed and replaced with bone during the healing process.

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#### Intended Use / Indications

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

#### Summary of Technology

Fortoss Vital™ is composed of porous calcium salts equivalent to that contained in the predicate devices and to that in routine clinical use. The technologies employed in Fortoss Vital™ and the predicate devices are therefore substantially equivalent. Fortoss Vital™ is presented in granules/powder in the same manner as the predicate devices. The indications, contraindications, risks and potential adverse events are the same and thus substantially equivalent.

#### Non Clinical Testing

Non clinical testing has been used to examine the chemical composition of Fortoss Vital™ which satisfies the standard for implantable calcium salts.

#### Clinical Testing

Fortoss Vital™ has been regularly used clinically and no adverse events have been reported in that time concerning the quality, safety or effectiveness of Fortoss Vital™.

#### Substantial Equivalence

Documentation provided demonstrates that Fortoss Vital™ is substantially equivalent to the legally marketed predicate devices in design, materials and indications. Fortoss Vital™ is well tolerated and completely incorporated into the defect site into which it is implanted and is safe and effective when used as indicated.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another, representing care and support.

Public Health Service

SEP 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biocomposites, Limited C/O Mr. Simon Fitzer Quality and Regulatory Affairs Manager Keele Science Park Keel Staffordshire UNITED KINGDOM ST5 5NL

Re: K050170

K030170
Trade/Device Name: Fortoss Vital™ Bone Graft Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: August 5, 2005 Received: August 9, 2005

Dear Mr. Fitzer:

This letter corrects our substantially equivalent letter of August 26, 2005.

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) profile is substantially equivalent (for the referenced above and nave celeminent to hegally marketed predicate devices marketed in
indications for use stated in the enclosure to tegated as a the Medical Device indications for use stated in the chelosates to the enactment date of the Medical Device interstate commerce prof to May 20, 1970, tile sified in accordance with the provisions of
Amendments or to devices that have been reclassified in accordance with the provisi Amendments of to devices that ilave been recurse approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval controls the Federal Frod, Drug, and Cosmetic Tict (110) adevice, subject to the general controls on approval (PMA). You may, therefore, market wis are and consected to the equirements for
provisions of the Act. The general controls provisions of the Act include requireme provisions of the Act. "The general concrease of the practice, labeling, and annual registrainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into existing major regulations affecting your
(PMA), it may be subject to additional controls. The Parts 800 to 808 . In (PMA), it may be subject to additional controllations, Title 21, Parts 800 to 898. In
device can be found in the Code of Federal Regulations, Title 21, Parts 80xiae in the F device can be found in the Code of Pederal Regarders, to the Federal Register.

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Page 2 - Mr. Fitzer

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DTC 3 losailes on that your device complies with other requirements mean that I DX mas made a astes and regulations administered by other Federal agencies. of the Act of ally I ederal states and regarments, including, but not limited to: registration You must comply with an the Act 3 requirements and 801); good manufacturing practice and ifsting (21 CFR Part 607), labeling (21 cm (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); a requirents as set forth in the quality is a control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section I ins letter will anow you to continue man man and of substantial equivalence of your device to 310(K) premarket notheated. Fice 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] picase contact the Office of Complimity of (2017)
(http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure) (21.05 (ittp://www.lua.gov.ouring by reference to premarket notification" (21 CFR note the regulation other general information on your responsibilities under the I alt 607.77). Tourina, obtain only geactional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Qur

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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K050170

### EXHIBIT 1

### INDICATIONS FOR USE

510(k) Number (if known):

Fortoss Vital™ Device Name:

Indications For Use:

Fortoss Vital ™ is intended for placement in osseous defects to provide a Fortoss Vital ™ Is intended for placement in occuration in axillofacial and dental implant surgery.

x Prescription Use (Part 21 CFR 801 Subpart D) OR

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)

Suren Rumpe

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

510(k) Number: K050170

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