TRICOS A RESORBABLE SUBSTITUTE

K081721 · Baxter Healthcare Corp · LYC · Aug 6, 2008 · Dental

Device Facts

• Record ID: K081721
• Device Name: TRICOS A RESORBABLE SUBSTITUTE
• Applicant: Baxter Healthcare Corp
• Product Code: LYC · Dental
• Decision Date: Aug 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

TricOs A is a resorbable bone void filler consisting of an inorganic calcium phosphate scaffold mixed with a heterologous human fibrin matrix. The fibrin matrix acts as a binder to improve handling characteristics 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. It lacks initial mechanical strength, necessitating the use of rigid fixation techniques. The material is resorbed over time as natural bone heals and replaces the scaffold. It is intended for clinical use in surgical settings.

Clinical Evidence

No clinical data. Evidence consists of nonclinical bench testing, biocompatibility testing, and animal studies (rabbit femoral condyles and sinus lift model) to verify performance as a bone void filler.

Technological Characteristics

Inorganic calcium phosphate scaffold with heterologous human fibrin matrix binder. Resorbable material. Complies with ISO 14971:2007 risk management standards. Sterilized via validated processes. Mechanical properties: non-load bearing (requires rigid fixation).

Indications for Use

Indicated for patients requiring bone void filling for non-structural osseous defects in the oral and maxillofacial region caused by surgery or traumatic injury.

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)
• Tricos T Resorbable Bone Substitute (K073571)

Submission Summary (Full Text)

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| 5. 510(K) SUMMARY | | | <br>12081721 | |
|--------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------|------------------------|--|
| DATE: | June 16, 2008 | | AUG - 6 2008 | |
| OWNER: | Baxter Healthcare Corporation | | | |
| | One Deerfield Parkway<br>Deerfield, IL 60015 | | | |
| CONTACT PERSON: | Barbara Barbeau | | | |
| | Senior Director, Global Regulatory Affairs | | | |
| | 1620 Waukegan Road, MPGR-AL | | | |
| | McGaw Park, IL 60085 | | | |
| | Telephone: [phone] | | | |
| | Fax: [phone] | | | |
| | Email: [e-mail] | | | |
| DEVICE NAME: | Trade Name: | Tricos A¹ Resorbable Bone<br>Substitute | | |
| | Common Name | Bone Void Filler | | |
| | Classification Name: | | Bone Grafting Material | |
| | Class: | Class II | | |
| | Product Code: | LYC, NUN | | |
| PREDICATE DEVICES: | Previously cleared 510(k)s for<br>Baxter Healthcare Corporation, Tricos T<br>Resorbable Bone Substitute product. | | | |
| | Previous 510(k) | Indication | Clearance Date | |
| | K051722 | Bone void filling of<br>the skeletal system | November 18, 2005 | |
| | K073571 | Bone void filling of | April 8, 2008 | |

the oral and

maxillofacial region

.

. .

¹ TricOs A is a trademark of Baxter Healthcare Corporation

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#### DEVICE DESCRIPTION:

TricOs A Resorbable Bone Substitute consists of an 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.

# STATEMENT OF INTENDED USE:

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

## TECHNOLOGICAL CHARACTERISTICS:

TricOs A 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) K073571 with regard to technological characteristics, performance, and intended use.

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## ASSESSMENT OF NONCLINICAL DATA:

Baxter Heathcare conducted a risk assessment according to the requirements of ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices. The TricOs T and TricOs A device material 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 of the skeleton system has been verified in animal studies using a rabbit femoral condyles model and through functional and biocompatibility testing. Device performance as a bone void filler in the oral and maxillofacial region has been addressed by comparative testing in a sinus lift animal model study and through functional and biocompatibility testing.

#### CONCLUSIONS:

The proposed TricOs A 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 device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG - 6 2008

Re: K081721

Trade/Device Name: TricOs A"" Resorbable Bone Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Codes: LYC, NUN Dated: June 16, 2008 Received: June 18, 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 (OS) 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,

Wamuel-Land, mr for //

ct

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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1

### 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K081721 New special 510(k)

Devicc Name:

TricOs A Resorbable Bone Substitute

Indication(s) for Use:

TricOs A 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 A 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 A Resorbable Bone Substitute is resorbed while providing support for the ingrowth of bone during the healing process. TricOs A Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

Susan Evans

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

510(k) Number: K081721

| Prescription Use: <span style="text-align:center">☑</span> | Over-the-Counter Use: <span style="text-align:center">☐</span> |
|------------------------------------------------------------|----------------------------------------------------------------|
| 21 CFR 801 Subpart D | 21 CFR Subpart C |

Concurrence of CDRH, Office of Device Evaluation (ODE)

¹ TricOs A is a trademark of Baxter Healthcare Corporation