TRIBONE 80

K071121 · Biomatlante · MQV · Sep 11, 2007 · Orthopedic

Device Facts

• Record ID: K071121
• Device Name: TRIBONE 80
• Applicant: Biomatlante
• Product Code: MQV · Orthopedic
• Decision Date: Sep 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TRIBONE 80™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. TRIBONE 80™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, TRIBONE 80™ gradually resorbs and is replaced with bone during the healing process. TRIBONE 80™ is to be used in association with adequate post-operative immobilization. TRIBONE 80™ is provided sterile for single patient use.

Device Story

TRIBONE 80™ is a biphasic calcium phosphate ceramic bone graft substitute; composed of 20% hydroxyapatite and 80% beta-tricalcium phosphate. Available in granules, sticks, and blocks; microporous and macroporous structure. Used by surgeons to fill bony voids or gaps in extremities, spine, and pelvis. Can be mixed with saline, patient serum, whole blood, bone marrow aspirate, or autograft. Device lacks intrinsic mechanical strength; requires rigid fixation and post-operative immobilization. Upon implantation, material gradually resorbs and is replaced by host bone during healing. Provided sterile for single-patient use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional characteristics compared to predicate devices.

Technological Characteristics

Biphasic calcium phosphate ceramic (20% Hydroxyapatite, 80% beta-Tricalcium Phosphate). Microporous and macroporous structure. Available in granules, sticks, and blocks. Sterile, single-use. No mechanical properties; requires external fixation.

Indications for Use

Indicated for patients requiring bone void filling in skeletal defects (extremities, spine, pelvis) not intrinsic to structural stability, including surgically created or traumatic osseous defects. Requires rigid fixation and post-operative immobilization.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• EOVIA (K040514)
• Bone Save (K033258)

Submission Summary (Full Text)

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K07/121

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## TRIBONE 80 ™

SEP 1 1 2007

# 510(k) Summary

BIOMATLANTE ZA DES IV NATIONS 5, rue Edouard Belin -F- 44360 VIGNEUX DE BRETAGNE Phone: [phone] Fax: [phone]

Contact: Laurence Letertre Regulatory Affairs Manager

This summary was prepared on April 200, 2007

### 1. DEVICE IDENTIFICATION

| Trade Name: | TRIBONE 80™ | |
|-----------------------|----------------------------------------------------|--|
| Common Name: | Resorbable bone substitute | |
| Classification Name : | Resorbable calcium salt bone void filler<br>device | |
| Product Code : | MQV | |
| Regulatory Status : | Class II | |
| CFR Section : | 888.3045 | |

#### 2. PREDICATE DEVICES

| Product Code | Applicant | 510(k) # | Product |
|--------------|-----------|----------|-----------|
| MQV | Orthotec | K040514 | EOVIA |
| MQV | Howmedica | K033258 | Bone Save |

#### 3. DEVICE DESCRIPTION

TRIBONE 80™ is a bone graft substitute. TRIBONE 80™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 20% Hydroxyapatite (HA) and 80% beta-Tricalcium Phosphate (ß-TCP). TRIBONE 80™ is available in granules, sticks and blocks. TRIBONE 80™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA). TRIBONE 80™ can also be mixed with autograft. TRIBONE 80™ is provided sterile for single patient use.

Rev. 9/10/2007

Section 04 Page 1 of 2

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# TRIBONE 80 ™

### 510(k) Summary

#### 4. INTENDED USE

TRIBONE 80™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

TRIBONE 80™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

When packed into a bony site, TRIBONE 80™ gradually resorbs and is replaced with bone during the healing process.

TRIBONE 80™ is to be used in association with adequate post-operative immobilization.

#### 5. SUBSTANTIAL EQUIVALENCE INFORMATION

The principal component and intended use of TRIBONE 80™ is the same as previously cleared devices. TRIBONE 80™ and the predicate device are substantially equivalent in design, materials of construction and function.

The safety and effectiveness of TRIBONE 80™ presented in this submission is adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification.

Rev. 9/10/2007

Section 04 Page 2 of 2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 1 2007

BIOMATLANTE % Ms. Adeline Filliâtre Regulatory Affairs Manager ZA DES IV NATIONS 5, rue Edouard Belin -F-44360 VIGNEUX DE BRETAGNE FRANCE

Re: K071121 Trade/Device Name: TRIBONE 80TM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: June 19, 2007 Received: August 2, 2007

Dear Mr. Filliâtre:

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. Iisting 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

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Page 2 - Ms. Adeline Filliâtre

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Buchholz

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for "Biomatlante". The logo consists of a black hexagon shape in the upper left corner, and the word "Biomatlante" is written in a simple, sans-serif font below and to the right of the hexagon. The text is in a lighter color, possibly gray or a light shade of blue. The overall design is clean and modern.

# TRIBONE 80™

## Indications for Use

510(k) Number (if known): K 071121

Device Name: TRIBONE 80 ™

Indications for Use:

#### INDICATIONS

TRIBONE 80™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

TRIBONE 80™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

When packed into a bony site, TRIBONE 80™ gradually resorbs and is replaced with bone during the healing process.

TRIBONE 80™ is to be used in association with adequate post-operative immobilization.

TRIBONE 80™ is provided sterile for single patient use.

Prescription Use (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)

Oulene Brielu Johnson
(Division Sign Off)

Rev. 9/10/2007

and Neurological De

Section 03 Page 1 of 1

**510(k) Number** Ko71121