DBX DEMINERALIZED BONE MATRIX PUTTY

K103784 · Musculoskeletal Transplant Foundation · MQV · Apr 13, 2011 · Orthopedic

Device Facts

• Record ID: K103784
• Device Name: DBX DEMINERALIZED BONE MATRIX PUTTY
• Applicant: Musculoskeletal Transplant Foundation
• Product Code: MQV · Orthopedic
• Decision Date: Apr 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DBX Putty is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX Putty can be used alone in the pelvis and extremities. DBX Putty can also be used as an extender in the pelvis and extremities with autograft. DBX can be used with bone marrow. DBX Putty is for single patient use only.

Device Story

DBX Putty and Inject are bone void fillers composed of demineralized cortical bone allograft and sodium hyaluronate in phosphate buffered saline. Sodium hyaluronate improves handling and maintains physiological pH. Devices are intended for use in surgically created or traumatic osseous defects in the pelvis and extremities. Used by surgeons in clinical settings to fill voids not intrinsic to bony stability. Applied alone, as an extender with autograft/allograft, or mixed with bone marrow. Osteoconductive properties; osteoinductive potential verified via athymic mouse model or alkaline phosphatase assay for lot release. Benefits include providing a scaffold for bone repair in non-structural defects.

Clinical Evidence

No clinical data provided. Evidence consists of in vivo studies demonstrating equivalence of the device used with autograft/allograft versus alone in the pelvis and extremities, and bench testing including biocompatibility (ISO 10993) and sterility (USP <71>). Osteoinductive potential is verified via athymic mouse model or alkaline phosphatase assay.

Technological Characteristics

Composition: Demineralized cortical bone allograft, sodium hyaluronate, phosphate buffered saline. Biocompatible and biodegradable. Sterilization: Aseptic processing, tested per USP <71>. Biocompatibility tested per ISO 10993. Osteoinductive potential verified via athymic mouse model or alkaline phosphatase assay. Single-donor processed.

Indications for Use

Indicated for treatment of surgically created or traumatic osseous defects in the pelvis and extremities in patients requiring bone void fillers. Not for use in defects intrinsic to bony structure stability. Can be used alone, with autograft/allograft, or with bone marrow.

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

• DBX® Putty (K040262)

Submission Summary (Full Text)

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APR 1 3 2011

# XII. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| PROPRIETARY NAME: | DBX® Demineralized Bone Matrix Putty |
|-----------------------------------|-----------------------------------------------------------------------|
| COMMON NAME: | Bone Void Filler Containing Human Demineralized Bone<br>Matrix (DBM) |
| PROPOSED REGULATORY<br>CLASS: | Class II |
| CLASSIFICATION<br>IDENTIFICATION: | 21 C.F.R. §888.3045 Resorable calcium salt bone void<br>filler device |
| PRODUCT CODE: | MBP, MQV. |
| SPONSOR: | Musculoskeletal Transplant Foundation |

125 May Street Edison, NJ 08837 732-661-0202

#### INDICATIONS FOR USE:

DBX Putty is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Putty can be used alone in the pelvis and extremities. DBX Putty can also be used as an extender in the pelvis and extremities with autograft. DBX can be used with bone marrow. DBX Putty is for single patient use only.

#### DEVICE DESCRIPTION:

DBX Putty is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Putty is cortical bone. Sodium hyaluronate is a naturally derived matcrial that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.

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### SAFTEY AND EFFECTIVENESS INFORMATION:

This 510(k) was submitted for an addition to the indications for use of DBX® Putty in the pelvis and extremities. Recent in vivo studies conducted by MTF demonstrate that the use of DBX Putty with autograft or allograft in the pelvis and extremities is equivalent to the use of DBX Putty alone. The fundamental scientific technology of the DBX® Putty with the expanded indications for use in the pelvis and extremities is the same as the technology for the predicate, DBX® Putty (FDA cleared, K040262).

Biocompatibility of DBX® materials has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. DBX® is single-donor processed using aseptic techniques and is tested for sterility per current USP <71>>.

#### OSTEOINDUCTIVE POTENTIAL

DBX Demineralized Bone Matrix is osteoconductive, and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final DBX Putty product is tested in an athymic mouse model or in an alkaline phosphatase assay, which has been shown to have a positive correlation with the athymic mouse model, to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse or alkaline phosphatase assay must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects.

### VIRAL CLEARANCE AND INACTIVATION:

The method for processing the DBM contained in DBX® was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses.

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# XII. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| PROPREIETARY NAME: | DBX® Demineralized Bone Matrix Inject |
|-----------------------------------|---------------------------------------------------------------------------------------------|
| COMMON NAME: | Bone Void Filler Containing Human Demineralized Bone<br>Matrix (DBM) |
| PROPOSED REGULATORY<br>CLASS: | Class II |
| CLASSIFICATION<br>IDENTIFICATION: | 21 C.F.R. §888.3045 Resorable calcium salt bone void<br>filler device |
| PRODUCT CODE: | MBP, MQV |
| SPONSOR: | Musculoskeletal Transplant Foundation<br>125 May Street<br>Edison, NJ 08837<br>732-661-0202 |

### INDICATIONS FOR USE:

DBX Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Inject can be used alone in the pelvis and extremities. DBX Inject can also be used as an extender in the pelvis and extremities with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.

### DEVICE DESCRIPTION:

DBX Inject is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Inject is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.

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#### SAFTEY AND EFFECTIVENESS INFORMATION:

This 510(k) was submitted for an addition to the indications for use of DBX® Inject in the pelvis and extremities. Recent in vivo studies conducted by MTF demonstrate that the use of DBX Inject with autograft or allograft in the pelvis and extremities is equivalent to the use of DBX Inject alone. The fundamental scientific technology of the DBX® Inject with the expanded indications for use in the pelvis and extremities is the same as the technology for the predicate, DBX® Putty (FDA cleared, K040262).

Biocompatibility of DBX® Inject materials has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. DBX® Inject is single-donor processed using aseptic techniques and is tested for sterility per current USP <71>.

# OSTEOINDUCTIVE POTENTIAL

DBX Inject is osteoconductive, and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final DBX Inject product is tested in an athymic mouse model or in an alkaline phosphatase assay, which has been shown to have a positive correlation with the athymic mouse model, to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse or alkaline phosphatase assay must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects.

## VIRAL CLEARANCE AND INACTIVATION:

The method for processing the DBM contained in DBX® Inject was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Musculoskeletal Transplant Foundation % Ms. Nancy Joy 125 May Street Edison, New Jersey 08837

APR 1 3 2011

Re: K103784

Trade/Device Name: DBX® Demineralized Bone Matrix Putty and Inject Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: March 07, 2011 Received: March 10, 2011

Dear Ms. Joy:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Nancy Joy

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Alij. B. R. for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# IV. INDICATIONS FOR USE

510(k) Number (if known): K103784

Device Name: DBX® Demineralized Bone Matrix Putty

Indications for Use:

DBX Putty is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Putty can be used alone in the pelvis and extremities. DBX Putty can also be used as an extender in the pelvis and extremities with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only.

X OR Prescription Use (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Yvonne L. Carey

(Division Sign 711 (Division Sign-On)
Division of Surgical, Orthopedic, Divisionative Devices

510(k) Number K103784

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# IV. INDICATIONS FOR USE

510(k) Number (if known): K103784

Device Name: DBX® Demineralized Bone Matrix Inject

Indications for Use:

DBX Inject is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX Inject can be used alone in the pelvis and extremities. DBX Inject can also be used as an extender in the pelvis and extremities with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.

X OR Prescription Use _ (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lawrence V. Bagby

(Division Sign-Off) (Division Sign-Sign-Sical, Orthopedic. Divisionative Devices

510(k) Number K103784