GRAFTON DBM

K051188 · Osteotech, Inc. · NUN · Jan 3, 2006 · Dental

Device Facts

• Record ID: K051188
• Device Name: GRAFTON DBM
• Applicant: Osteotech, Inc.
• Product Code: NUN · Dental
• Decision Date: Jan 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GRAFTON® DBM is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON® DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON® DBM is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.

Device Story

GRAFTON® DBM is a human bone allograft containing demineralized bone matrix (DBM) and an inert carrier; provided in various physical forms (Gel, Flex, Putty, Matrix, Crunch). Used by clinicians to fill or augment non-structural bony voids in dental, oral, and cranio-/maxillofacial sites. Implanted via manual packing into defects; acts as an osteoconductive and osteoinductive scaffold. Resorbed and remodeled by host bone during healing. Proprietary processing includes validated viral inactivation steps (HIV-1, HBV, HCV, CMV, Polio).

Clinical Evidence

Performance supported by animal and human studies showing performance comparable to autograft and other DBM products. Osteoinductivity confirmed via athymic rat assay using a five-point linear scale at 28 days. Viral inactivation validated against HIV-1, HBV, HCV, CMV, and Polio virus.

Technological Characteristics

Human demineralized bone matrix (DBM) with inert carrier. Malleable/flexible form factor for manual molding/cutting. Osteoconductive and osteoinductive. Validated proprietary viral inactivation process. Provided ready-to-use for single patient application.

Indications for Use

Indicated for patients requiring filling or augmentation of dental intraosseous, oral, and cranio-/maxillofacial bony voids or gaps not intrinsic to structural stability. Applicable to surgically created defects or traumatic bone injuries, including periodontal/infrabony defects, alveolar ridge augmentation, dental extraction sites, sinus lifts, and cystic 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.

Submission Summary (Full Text)

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# XII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

December 16, 2005

- 1. Submission Applicant & Correspondent:

| Name: | Osteotech, Inc. |
|-----------------|-------------------------------------|
| Address: | 51 James Way<br>Eatontown, NJ 07724 |
| Phone No .: | [phone] |
| Contact Person: | Chris Talbot |

- 2. Name of Product:

| Trade/Proprietary/Model Name: | GRAFTON® DBM (Gel, Flex, Putty, Matrix, Crunch) |
|-------------------------------|-------------------------------------------------|
| Common or Usual Name: | Demineralized Bone Matrix Allograft |
| Classification Name: | Bone Grafting Material |

- 3. Devices to Which New Product is Substantially Equivalent:
GRAFTON® DBM is substantially equivalent, for the purpose of this 510(k), to other devices that have received 510(k) clearance for similar indications for use.

In addition, GRAFTON® DBM is substantially equivalent to human freeze dried bone, such as demineralized bone matrix, to which one or more predicate devices in this device category have claimed substantial equivalence.

- 4. Device Description:
GRAFTON® DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative handling. It is intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. GRAFTON® DBM is provided ready-to-use in various physical forms. It is packaged in various sizes by volume or dimension for single patient use.

GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary processing method of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON® DBM finished product for osteoinductivity in this validated athymic rat assay utilizing a

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five-point linear scale (0,1,2,3,4) to score bone formation at 28 days*. This bone forming activity exhibited by GRAFTON® DBM in this athymic rat surrogate assay should not be interpreted as a predictor of clinical performance.

*Edwards, J.T., PhD, Diegmann, M.H., MS, Scarborough, N.L., PhD.: Osteoinduction of Human Demineralized Bone: Characterization in a Rat Model. Clinical Orthopaedics, December, 1998, Volume 357.

### 5. Intended Use/Indications

GRAFTON® DBM is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON® DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON® DBM is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.

## 6. Technical Comparison

GRAFTON® DBM is substantially equivalent to one or more of the predicate devices with respect to materials in that it contains human demineralized hone matrix (DBM) in a resorbable non-tissue additive or carrier. It is provided readyto-use in various malleable/flexible forms that can be molded, manipulated on cut by the user into various shapes or sizes. It is implanted in this malleable/flexible state.

# 7. Performance Data

The results of studies in animals and humans show that GRAFTON® DBM performs at least as well as, if not better than, predicate devices, autograft and/or demineralized bone matrix. Additional relevant animal and clinical data exist that support the successful performance of GRAFTON® DBM.

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## 8. Viral Inactivation

GRAFTON® DBM is produced by a proprietary production process that has been validated to inactivate viruses including: HIV-1; hepatitis B virus (duck hepatitis virus as model); hepatitis C virus (bovine diarrhea virus as model), CMV; and Polio virus. This process is used to further reduce the risk of disease transmission via the use of this product beyond the protection provided by donor testing and screening procedures.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread.

Public Health Service

2006 JAN 3

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christopher Talbot Director, Regulatory Affairs Osteotech, Incorporated 51 James Way Eatontown, New Jersey 07724

Re: K051188

Trade/Device Name: GRAFTON® DBM Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: December 19, 2005 Received: December 20, 2005

Dear Mr Talbot:

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 – Mr. Talbot

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,

Chiu-Lin, Ph.D.

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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K051188

Indications for Use - Statement 111.

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: GRAFTON® DBM

Indications for Use:

GRAFTON® DBM is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts: cystic defects: craniofacial augmentation. GRAFTON® DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON® DBM is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is absorbed/remodeled and replaced by host bone during the healing process.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pearson

KOS 1182