GRAFTON PLUS DBM PASTE

K042707 · Osteotech, Inc. · NUN · Nov 30, 2005 · Dental

Device Facts

• Record ID: K042707
• Device Name: GRAFTON PLUS DBM PASTE
• Applicant: Osteotech, Inc.
• Product Code: NUN · Dental
• Decision Date: Nov 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GRAFTON PLUS® DBM Paste 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 PLUS® DBM Paste 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 PLUS® DBM Paste is indicated only for bony voids or gans that are . not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.

Device Story

GRAFTON PLUS® DBM Paste is a human bone allograft consisting of demineralized bone matrix (DBM) and an inert starch-based additive. Provided as a ready-to-use, malleable paste; manipulated by clinicians to fill dental, oral, and cranio-/maxillofacial bony voids. Used alone or as a bone graft extender mixed with autograft/allograft bone or bone marrow. Implanted into non-load-bearing defects; resorbed and replaced by host bone during healing. Osteoinductive properties validated via ectopic bone formation in athymic rat model.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing and animal model studies. Osteoinductivity was confirmed using an athymic rat model, demonstrating consistent bone formation.

Technological Characteristics

Human demineralized bone matrix (DBM) combined with an inert starch-based additive. Malleable, ready-to-use paste form. Does not set or harden. Resorbable. No energy source or software components.

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 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.

Predicate Devices

• TBM Sponge (K960267)
• PerioGlass-BioGlass Bone Graft Particulate (K040278)
• Calcium Hydroxylapatite Implant (K030682)
• PerioGlass Plus-Settable Bone Graft Substitute (K031073)

Submission Summary (Full Text)

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NOV 3 0 2005

K042707

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

September 29, 2004

- 1. Submission Applicant & Correspondent:
Name: Address:

Phone No.: Contact Person:

Osteotech. Inc. 51 James Way Eatontown, NJ 07724 [phone] Chris Talbot

- 2. Name of Product:

| Trade/Proprietary/Model Name: | GRAFTON PLUS® DBM Paste |
|-------------------------------|-------------------------------------|
| Common or Usual Name: | Demineralized Bone Matrix Allograft |
| Classification Name: | Bone Grafting Material |

- 3. Devices to Which New Product is Substantially Equivalent:
Grafton Plus DBM Paste is substantially equivalent, for the purpose of this 510(k), to the following predicate devices.

| Trade/Proprietary/Model Name | Manufacturer | 510(K) # |
|---------------------------------------------------|-------------------------|----------|
| TBM Sponge | Biocoll Laboratories | K960267 |
| PerioGlass-BioGlass Bone<br>Graft Particulate | NovaBone Products, Inc. | K040278 |
| Calcium Hydroxylapatite Implant | BioForm, Inc. | K030682 |
| PerioGlass Plus-Settable Bone<br>Graft Substitute | NovaBone Products, Inc. | K031073 |

In addition, GRAFTON PLUS® DBM Paste 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 PLUS® DBM Paste is a human bone allograft product consisting of human demineralized bone matrix (DBM) mixed with an inert starch-based additive. It is intended to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. GRAFTON PLUS® DBM Paste is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is provided in various package sizes by volume.

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GRAFTON PLUS® DBM Paste is an osteoinductive bone graft product in that it forms ossicles of bone when implanted ectopically in an athymic rat model. It is produced using a process that has been validated to consistently produce osteoinductive DBM as measured in the athymic rat test model.

## 5. Intended Use/Indications

GRAFTON PLUS® DBM Paste 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 PLUS® DBM Paste 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 PLUS® DBM Paste is indicated only for bony voids or gans that are . not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.

- 6. Technical Comparison
GRAFTON PLUS® DBM Paste is substantially equivalent to one or more predicate devices with respect to materials in that it consists of human demineralized bone matrix and an inert non-tissue additive. It is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is implanted in this malleable state and does not set or harden prior to or after implantation.

## 7. Performance Data

Studies of bone formation with GRAFTON PLUS® DBM Paste were conducted using an animal model. These studies demonstrated consistent bone formation with GRAFTON PLUS® DBM Paste.

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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 an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2005

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

Re: K042707

Trade/Device Name: GRAFTON PLUS® DBM Paste Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: November 21, 2005 Received: November 22, 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 (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,

Chiu-Lin, Ph.D.

Chiu Lin, Ph.Ď. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K042707

III. Indications for Use - Statement

510(k) Number (if known):

Device Name: GRAFTON PLUS® DBM Paste

Indications for Use:

GRAFTON PLUS®DBM Paste 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 PLUS® DBM Paste 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 PLUS® DBM Paste is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON PLUS® DBM Paste is absorbed/remodeled and replaced by host bone during the healing process.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russoe

on of Anesthesiology, G Control, Control, Dental D

Number: k042707

Prescription Use
(Per 21 CFR 801.109)

OR

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