VIAGRAF DBM PASTE

K043209 · Osteotech, Inc. · MBP · Dec 5, 2005 · Orthopedic

Device Facts

• Record ID: K043209
• Device Name: VIAGRAF DBM PASTE
• Applicant: Osteotech, Inc.
• Product Code: MBP · Orthopedic
• Decision Date: Dec 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VIAGRAF® DBM Paste is intended for use in filling bony voids or gaps of the extremities that are not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. VIAGRAF® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.

Device Story

VIAGRAF DBM Paste is an osteoconductive bone void filler composed of human demineralized bone matrix (DBM) and an inert starch-based carrier. Provided as a ready-to-use, malleable paste; molded by surgeons to fill non-structural bony defects in extremities. Device acts as a scaffold; resorbed and remodeled by host bone during healing. Proprietary production process includes viral inactivation steps for HIV-1, hepatitis B, hepatitis C, CMV, and Polio virus. Used in clinical settings for orthopedic procedures.

Clinical Evidence

Evidence includes animal model studies demonstrating acceptable bone formation and supporting clinical data. No specific metrics or sample sizes provided.

Technological Characteristics

Composition: Human demineralized bone matrix (DBM) and inert starch-based carrier. Form: Malleable, ready-to-use paste. Sterilization: Proprietary viral inactivation process (HIV-1, HBV, HCV, CMV, Polio).

Indications for Use

Indicated for filling non-structural bony voids or gaps in extremities caused by surgical defects or traumatic injury. For prescription use.

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

• Exactech Resorbable Bone Paste (K020078)
• Exactech Resorbable Room Temperature Bone Paste (K040755)
• Allomatrix Putty (K020895)
• Allomatrix Putty (K041186)

Submission Summary (Full Text)

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K043209

#### 2005 DEC 5

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

#### November 16, 2004

- 1. Submission Applicant & Correspondent:

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

- 2. Name of Product:

| Trade/Proprietary/Model Name: | VIAGRAF ◊ DBM Paste |
|-------------------------------|-------------------------------------|
| Common or Usual Name: | Demineralized Bone Matrix Allograft |
| Classification Name: | Resorbable Bone Void Filler |

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

| Trade/Proprietary/Model Name | Manufacturer | 510(K) # |
|----------------------------------------------------|----------------|----------|
| Exactech Resorbable Bone Paste | Exactech | K020078 |
| Exactech Resorbable Room<br>Temperature Bone Paste | Exactech | K040755 |
| Allomatrix Putty | Wright Medical | K020895 |
| Allomatrix Putty | Wright Medical | K041186 |

- 4. Device Description:
VIAGRAF DBM Paste is an osteoconductive human bone allograft product consisting of human demineralized bone matrix (DBM) to which an inert starchbased carrier has been added. It is intended for use in filling bony voids or gaps of the extremities not intrinsic to the stability of the bony structure. VIAGRAF® 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.

- 5. Intended Use/Indications
VIAGRAF DBM Paste is intended for use in filling bony voids or gaps of the extremities that are not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury

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to the bone. VIAGRAF® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.

#### 6. Technical Comparison

VIAGRAF® DBM Paste is substantially equivalent to one or more of the predicate devices with respect to materials in that it consists of human demineralized bone matrix (DBM) and an inert resorbable non-tissue additive or carrier. It is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes.

### 7. Performance Data

The results of bone formation studies in animal models demonstrated acceptable bone formation with VIAGRAF® DBM Paste. In addition, relevant clinical data exists that supports the performance of VIAGRAF® DBM Paste.

### 8. Viral Inactivation

VIAGRAF® DBM Paste 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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Public Health Service

DEC 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Christopher Talbot Director, Regulatory Affairs Osteotech, Inc. 51 James Way Eatontown, NJ 07724

Re: K043209

VIAGRAF® DBM Paste Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MQV Dated: October 27, 2005 Received: October 28, 2005

Dear Mr. Talbot:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beener been 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 Interstate conmiseree prior to ria) 20, 2011 reclassified in accordance with the provisions of Amendinents, or to de rouses 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 approval application (114) in the general controls provisions of the Act include controls provisions of the engistration, 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 (FMA), it may of subject to back adalaf Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be acrisod that 1 Da determination that your device complies with other requirements mean that + D7 mas mass statutes and regulations administered by other Federal agencies.

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Page 2 – Mr. Christopher Talbot

You must comply with all the Act's requirements, including, but not limited to: registration 1 our intest comply William (21 CFR Part 801); good manufacturing practice alle houng (21 CF ref art of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify ijon 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 This letter inn and in Justication. The FDA finding of substantial equivalence of your device s ro 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), 11 you desire specifice 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 may overni 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,

Mark N. Mellon

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

Enclosure

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#### Attachment 3

III. Indications for Use - Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K043209

Device Name: VIAGRAF® DBM Paste

Indications for Use:

VIAGRAF® DBM Paste is intended for use in filling bony voids or gaps of the extremities that are not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. VIAGRAF® DBM Paste is resorbed/remodeled and is 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

**vision Sign-Off**

Division of General, Restorative, and Neurological Devices

510(k) Number_ K043 209