GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES

K082615 · Osteotech, Inc. · MQV · Oct 16, 2008 · Orthopedic

Device Facts

• Record ID: K082615
• Device Name: GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES
• Applicant: Osteotech, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Oct 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GRAFTON®II eDBM is intended for use as a 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®II eDBM is resorbed/remodeled and is replaced by host bone during the healing process.

Device Story

GRAFTON®II eDBM is a human bone allograft consisting of demineralized bone matrix (DBM) and surface demineralized cortical bone chips contained within an absorbable mesh pouch. Designed for intraoperative handling, the device is provided ready-to-use in a malleable, flexible state that does not harden. It is used by surgeons to fill non-structural bony voids or gaps in the spine, pelvis, or extremities. The graft may be secured with sutures, staples, or wires. The device is osteoconductive and osteoinductive; it is resorbed and replaced by host bone during the healing process. Processing includes validated viral inactivation steps for HIV-1, hepatitis B, hepatitis C, CMV, and Polio virus. The device is intended for single patient use.

Clinical Evidence

Bench testing and in vivo animal studies were provided. Osteoinductivity is confirmed via a validated athymic rat assay using a five-point linear scale to score bone formation at 28 days. Animal study results indicate performance at least as well as, or better than, predicate devices and autograft. No human clinical trial data is presented as the primary basis for equivalence.

Technological Characteristics

Human bone allograft (DBM and cortical bone chips) in an absorbable mesh pouch. Osteoconductive and osteoinductive. Malleable/flexible form factor; does not harden. Provided ready-to-use. Viral inactivation validated for HIV-1, HBV, HCV, CMV, and Polio. No electronic components or software.

Indications for Use

Indicated for patients requiring bone graft substitutes or void fillers in the skeletal system (spine, pelvis, extremities) for non-structural bony defects caused by surgery or trauma.

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

• GRAFTON® I eDBM

Submission Summary (Full Text)

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## September 5, 2008

- 1. Submission Applicant & Correspondent:
Name: Address: Phone No.: Contact Person:

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

- 2. Name of Product:

| Trade/Proprietary/Model Name: | GRAFTON®II eDBM |
|-------------------------------|-------------------------------------|
| Common or Usual Name: | Demineralized Bone Matrix Allograft |
| Classification Name: | Resorbable Bone Void Filler |

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

- 4. Device Description:
GRAFTON®II eDBM is a human bone allograft product containing human demineralized bone matrix (DBM) and surface demineralized cortical bone chips sealed in an absorbable mesh pouch for intraoperative handling. 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®II eDBM is provided ready-to-use in various package sizes by volume or dimension and is intended for single patient use.

GRAFTON®II eDBM 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 shown to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON®II eDBM finished product for osteoinductivity in this 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®II eDBM in the athymic rat surrogate assay should not be interpreted as a predictor of human clinical performance.

*Edwards, J.T., PhD, Diegmann, M.H., MS, Scarborough, N.L., PhD.: Osteoinduction of Human Demineralized Bone: Characterization in a Rat Morrogh, N.E., HD. Octobilduction in Hunlan, Malan, National, Nature, 1998, Volume 357.

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## 5. Intended Use/Indications

GRAFTON®II eDBM is intended for use as a 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®II eDBM is resorbed/remodeled and is replaced by host bone during the healing process.

- 6. Technical Comparison
GRAFTON®II eDBM is substantially equivalent to one or more of the predicate devices with respect to materials in that it contains human demineralized bone matrix (DBM) and surface demineralized cortical bone chips. It is provided ready-to-use in various forms that can be manipulated by the user to contour the surgical site and may be secured to the graft site with sutures, staples or wires if the surgeon desires. GRAFTON®II eDBM is implanted in this malleable/flexible state and does not harden prior to or after implantation.

- 7. Performance Data
The results of in vivo studies in animals showed that GRAFTON®II eDBM performs at least as well as, if not better than, predicate devices and/or autograft. Additional relevant animal and clinical data exist that support the successful performance of demineralized bone matrix in GRAFTON®II eDBM.

- 8. Viral Inactivation
GRAFTON®II eDBM fibers and chips are produced by proprietary processing steps that have been validated or shown 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. These processes are 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", indicating the department's name and national affiliation.

OCT 1 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Osteotech, Inc. % Mr. Chris Talbot Director, Regulatory Affairs 51 James Way Eatontown, New Jersey 07724

Re: K082615

Trade/Device Name: GRAFTON® II eDBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: September 05, 2008 Received: September 09, 2008

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. 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.

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Page 2 -- Mr. Chris Talbot

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Wilkerson

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

Enclosure

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VI. Indications for Use - Statement

5082615 510(k) Number (if known):

Device Name: GRAFTON® II e DBM

Indications for Use:

GRAFTON® II eDBM is intended for use as a 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®II eDBM 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chillinave. ang h

**510(k) Number** k 982618

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