DBX DEMINERALIZED BONE MATRIX PUTTY

K103795 · Musculoskeletal Transplant Foundation · MQV · Apr 13, 2011 · Orthopedic

Device Facts

• Record ID: K103795
• 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 posterolateral spine. DBX Putty can also be used as an extender in the spine with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only. 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 posterolateral spine. DBX Inject can also be used as an extender in the spine with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.

Device Story

DBX Putty and Inject are bone void fillers composed of human cortical demineralized bone matrix (DBM) and sodium hyaluronate in phosphate buffered saline. Sodium hyaluronate acts as a carrier to improve handling and maintain physiological pH. Devices are intended for surgical use by physicians to fill osseous defects. Osteoinductive potential is verified for every lot via athymic mouse model or alkaline phosphatase assay. Processing includes viral inactivation steps. Devices are single-donor processed using aseptic techniques. Clinical benefit derived from osteoconductive and osteoinductive properties supporting bone healing in non-structural voids.

Clinical Evidence

Bench testing only. Osteoinductive potential established via athymic mouse model or alkaline phosphatase assay; positive correlation between assay and mouse model demonstrated. Viral inactivation potential validated using a panel of model human viruses. Biocompatibility established per ISO 10993.

Technological Characteristics

Composition: Human cortical demineralized bone matrix (DBM) and sodium hyaluronate in phosphate buffered saline. Biocompatible and biodegradable. Sterilization: Aseptic processing; sterility tested per USP <71>. Osteoinductive verification: Athymic mouse model or alkaline phosphatase assay.

Indications for Use

Indicated for patients requiring treatment of surgically created or traumatic osseous defects not intrinsic to bony stability. Suitable for use in the posterolateral spine, either alone, as an extender with autograft/allograft, or with bone marrow. Single patient use only.

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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# 103795 DBX® 510(k)

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

APR 1 3 2011

| PROPRIETARY NAME: | DBX® Demineralized Bone Matrix Putty |
|-----------------------------------|---------------------------------------------------------------------------------------------|
| COMMON NAME: | Bone Void Filler Containing Human Demineralized<br>Bone Matrix (DBM) |
| PROPOSED REGULATORY<br>CLASS: | Class II |
| CLASSIFICATION<br>IDENTIFICATION: | 21 C.F.R. §888.3045 Resorbable calcium salt bone<br>void 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 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 posterolateral spine. DBX Putty can also be used as an extender in the spine with autograft or allograft. DBX Putty 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 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® Putty in the posterolateral spine. Based on a recent in vivo study, DBX® Putty can be used as an extender in the spine with allograft. The fundamental scientific technology of the DBX® Putty with expanded indications for use in the posterolateral spinc 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<br>Bone Matrix (DBM) |
| PROPOSED REGULATORY<br>CLASS: | Class II |
| CLASSIFICATION<br>IDENTIFICATION: | 21 C.F.R. §888.3045 Resorable calcium salt bone<br>void 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 posterolateral spine. DBX Inject can also be used as . an extender in the spine 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 Demincralized 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 posterolateral spine. Based on a recent in vivo study, DBX® Inject can be used as an extender in the spine with allograft. The fundamental scientific technology of the DBX® Inject with expanded indications for use in the posterolateral spine is the same as the technology for the predicate DBX® Putty (FDA cleared, K040262).

Biocompatibility of DBX® Inject matcrials 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 body and wings. The eagle is positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

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 2311

Re: K103795

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/ucm115809htm 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Aiz B. M. he
fer

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): K103795

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

' OR Prescription Use _ X (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)

Division Sign Off

(Division Sign-Off (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103795

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## IV. INDICATIONS FOR USE

510(k) Number (if known): K103795

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

OR Prescription Use _ X (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)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative of Surgical, Original, Oricand Restorative Devices

510(k) Number K103795