TRICOS T RESORBABLE BONE SUBSTITUTE

K073571 · Baxter Healthcare Corporation · LYC · Apr 8, 2008 · Dental

Device Facts

• Record ID: K073571
• Device Name: TRICOS T RESORBABLE BONE SUBSTITUTE
• Applicant: Baxter Healthcare Corporation
• Product Code: LYC · Dental
• Decision Date: Apr 8, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TricOs T Resorbable Bone Substitute is indicated for use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs T Resorbable Bone Substitute is intended to fill, augment, or reconstruct bony defects of the oral and maxillofacial region. Following placement in bony voids or gaps, TricOs T Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process. TricOs T Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

Device Story

TricOs T Resorbable Bone Substitute is a bone void filler composed of an inorganic calcium phosphate scaffold mixed with a heterologous human fibrin matrix. The fibrin matrix acts as a binder to improve handling and provides a 3D scaffold for bone in-growth. The device is applied by a surgeon to fill, augment, or reconstruct bony defects in the oral and maxillofacial region. Because the material lacks initial mechanical strength, rigid fixation is required. The device is resorbed over time as new bone grows into the site. It is intended for clinical use by surgeons.

Clinical Evidence

No human clinical data provided. Evidence consists of comparative nonclinical bench testing and an animal model study (sinus lift) to evaluate performance in the oral and maxillofacial region.

Technological Characteristics

Inorganic calcium phosphate scaffold mixed with heterologous human fibrin matrix. Resorbable bone void filler. No initial mechanical properties. Materials and components meet established testing and sterilization standards.

Indications for Use

Indicated for patients requiring bone void filling in surgically created or traumatic osseous defects, specifically for filling, augmenting, or reconstructing bony defects in the oral and maxillofacial region. Not for use in voids intrinsic to bony structure stability.

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

• TricOs T Resorbable Bone Substitute (K051722)
• Geistlich BIO-OSS®, BIO-OSS® Blocks and BIO-OSS® Collagen (K033815)

Submission Summary (Full Text)

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| 5. 510(K) SUMMARY | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE: | March 10, 2008 APR - 8 2008 |
| OWNER: | Baxter Healthcare Corporation<br>One Deerfield Parkway<br>Deerfield, IL 60015 |
| CONTACT PERSON: | Barbara Barbeau<br>Senior Director, Global Regulatory Affairs<br>1620 Waukegan Road, MPGR-AL<br>McGaw Park, IL 60085<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| DEVICE NAME: | Proprietary Name: TricOs T' Resorbable Bone<br>Substitute<br>Common/Usual Name: Bone Void Filler<br>Classification Name: Resorbable Calcium Salt Bone<br>Void Filler<br>Product Code: LYC |
| PREDICATE DEVICES: | TricOs T Resorbable Bone Substitute (K051722)<br>Geistlich BIO-OSS®, BIO-OSS® Blocks and BIO-<br>OSS® Collagen (K033815) |
| STATEMENT OF<br>INTENDED USE: | TricOs T Resorbable Bone Substitute is indicated for<br>use as a bone void filler for voids and gaps that are not<br>intrinsic to the stability of the bony structure. It is<br>indicated for surgically created osseous defects or<br>osseous defects resulting from traumatic injury.<br>TricOs T Resorbable Bone Substitute is intended to fill,<br>augment, or reconstruct bony defects of the oral and<br>maxillofacial region. Following placement in bony<br>voids or gaps, TricOs T Resorbable Bone Substitute is |

I TricOs T is a trademark of Baxter Healthcare Corporation

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resorbed while providing support for the in-growth of bone during the healing process. TricOs T Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended. TricOs T Resorbable Bone Substitute consists of an DEVICE DESCRIPTION:

inorganic calcium phosphate scaffold that is mixed with a heterologous human fibrin matrix prior to application. The fibrin matrix acts as a binder for the calcium phosphate scaffold, imparting favorable handling characteristics to the product to facilitate the surgical procedure, and acting as a three-dimensional matrix that supports the in-growth of bone.

## TECHNOLOGICAL CHARACTERISTICS:

TricOs T Resorbable Bone Substitute for oral and maxillofacial region is substantially equivalent to Baxter's current legally marketed TricOs T Resorbable Bone Substitute cleared by 510(k) K051722 with regard to technological characteristics, performance, and components. The Baxter TricOs T Resorbable Bone Substitute is intended for oral and maxillofacial applications in the same capacity as the BIO-OSS®, BIO-OSS® Blocks and BIO-OSS® Collagen products (K033815).

### ASSESSMENT OF NONCLINICAL DATA:

The intended use of the subject device is being expanded to include bone void filling for the oral and maxillofacial region of the skeleton. The subject and predicate TricOs T device materials and component specifications are similar. The device components continue to meet the same material testing standards, and sterilization processing standards. Device performance as a bone void filler in the oral and maxillofacial region of the skeleton has been addressed by comparative testing in a sinus lift animal model

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study. The results obtained from this study support the claim for substantial equivalence to BIO-OSS® devices for the new intended use.

#### CONCLUSIONS:

The proposed TricOs T Resorbable Bone Substitute has been verified against established standards and guidelines for its intended use. Testing demonstrates that the proposed device is as safe and effective as the predicate devices and the TricOs T Resorbable Bone Substitute performs well in skeletal and oral and maxillofacial region.

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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Barbara K. Barbeau Sr. Director, Global Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road MP GR-AL McGaw Park, IL 60085

APR - 8 2008

Re: K073571

Trade/Device Name: TricOs T™ Resorbable Bone Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Codes: LYC and NUN Dated: March 31, 2008 Received: April 1, 2008

Dear Ms. Barbeau:

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. Barbeau

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

Sincerely yours,

Snute Y. Michael Omd.

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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# 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K073571

Device Name:

TricOs T Resorbable Bone Substitute

#### Indication(s) for Use:

TricOs T Resorbable Bone Substitute is indicated for use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs T Resorbable Bone Substitute is intended to fill, augment, or reconstruct bony defects of the oral and maxillofacial region. Following placement in bony voids or gaps, TricOs T Resorbable Bone Substitute is resorbed while providing support for the ingrowth of bone during the healing process. TricOs T Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

| Prescription Use: | <div> <span> </span> <span> </span> </div> |
|-----------------------|--------------------------------------------|
| 21 CFR 801 Subpart D | |
| Over-the-Counter Use: | <div> <span> </span> <span> </span> </div> |
| 21 CFR Subpart C | |

Concurrence of CDRH, Office of Device Evaluation (ODE WADN

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

1 TricOs T is a trademark of Baxter Healthcare Corporation

10(k) Number: Kr73571