GRAFTON PLUS DBM PASTE

K043048 · Osteotech, Inc. · MBP · Nov 23, 2005 · Orthopedic

Device Facts

• Record ID: K043048
• Device Name: GRAFTON PLUS DBM PASTE
• Applicant: Osteotech, Inc.
• Product Code: MBP · Orthopedic
• Decision Date: Nov 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Grafton Plus® DBM Paste is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) 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. 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 carrier. Provided as a ready-to-use, malleable paste, it is manipulated by surgeons to fill bony voids or gaps in the spine, pelvis, and extremities. The device acts as an osteoconductive and osteoinductive scaffold that is resorbed and replaced by host bone during the healing process. It is used in clinical settings by surgeons to address defects resulting from surgery or trauma. The device undergoes a proprietary processing method validated to inactivate viruses (HIV-1, HBV, HCV, CMV, Polio) to reduce disease transmission risk. It provides a bone graft substitute/extender to facilitate skeletal repair.

Clinical Evidence

Evidence includes bone formation studies in animal models showing performance comparable to autograft. Osteoinductivity is confirmed via a validated athymic rat assay using a five-point linear scale to score bone formation at 28 days. No human clinical trial data is presented in the summary.

Technological Characteristics

Human demineralized bone matrix (DBM) combined with an inert starch-based carrier. Malleable, ready-to-use paste form. Osteoconductive and osteoinductive properties. Proprietary viral inactivation process validated for HIV-1, HBV, HCV, CMV, and Polio virus.

Indications for Use

Indicated for patients requiring bone graft extension, substitution, or void filling in the skeletal system (spine, pelvis, extremities) for surgically created or traumatic defects not intrinsic to bony stability.

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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NOV 2 3 2005

K043048

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

#### November 17, 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 PLUS® 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:
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) # |
|----------------------------------------------------|----------------|----------|
| 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:
GRAFTON PLUS® DBM Paste is a human bone allograft product consisting of human demineralized bone matrix (DBM) to which an inert starch-based carrier has been added. It is intended for use in filling bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. 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.

GRAFTON PLUS® DBM Paste 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 PLUS® DBM Paste finished product for osteoinductivity in this

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validated athymic rat assay utilizing a five-point linear scale (0,1,2,3,4) to score bone formation at 28 days*. This bone forming activity exhibited by GRAFTON PLUS® DBM Paste 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 PLUS® DBM Paste is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) not intrinsic to the stability of the bonv structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. 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 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 animals showed that GRAFTON PLUS® DBM Paste performed comparably to autograft. Additional relevant animal and clinical data exist that support the performance of GRAFTON PLUS® DBM Paste.

# 8. Viral Inactivation

GRAFTON PLUS® 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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2005

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

Re: K043048

GRAFTON PLUS® DBM Paste Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP Dated: November 10, 2005 Received: November 14, 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.

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.

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#### Page 2 - Mr. Christopher Talbot

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,

Z

Mark 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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#### Indications for Use - Statement III.

K043048 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: GRAFTON PLUS® DBM Paste

Indications for Use:

Grafton Plus® DBM Paste is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system grant babothates) and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects strated by traumatic injury to the bone. Grafton Plus® DBM Paste is oreatou by tradmatic injury replaced by host bone during the healing process.

Prescription Use × (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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_KO43048