MTF NEW BONE VOID FILLER

K110003 · Musculoskeletal Transplant Foundation · MQV · Oct 13, 2011 · Orthopedic

Device Facts

• Record ID: K110003
• Device Name: MTF NEW BONE VOID FILLER
• Applicant: Musculoskeletal Transplant Foundation
• Product Code: MQV · Orthopedic
• Decision Date: Oct 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. It is for use in the posterolateral spine only, for posterolateral spine fusions. The MTF New Bone Void Filler must be used in the spine with bone marrow aspirate. The MTF New Bone Void Filler is for single patient use only.

Device Story

MTF New Bone Void Filler consists of processed human demineralized bone matrix (DBM) combined with gelatin and sodium hyaluronate. Supplied as a mixture requiring hydration with bone marrow aspirate; spatula provided for mixing. Surgeon manipulates resulting putty into desired shape for application into non-structural osseous defects in the posterolateral spine. Device acts as an osteoconductive scaffold; osteoinductive potential verified via athymic mouse model testing for each lot. Intended for single-patient use in surgical settings to facilitate bone fusion. Benefits include flexibility and ease of handling during orthopedic procedures.

Clinical Evidence

No clinical data in human subjects provided. Evidence consists of bench testing and animal model studies. Osteoinductive potential verified in athymic mouse model for every lot. Performance evaluated in a rabbit model of posterolateral lumbar fusion.

Technological Characteristics

Processed human demineralized bone matrix, gelatin, and sodium hyaluronate (non-animal origin). Biocompatible and biodegradable. Supplied as a mixture requiring hydration. Aseptically processed; passes USP <71> sterility testing. Complies with 21 CFR Part 1270 and 1271 for human tissue.

Indications for Use

Indicated for treatment of surgically created or traumatic osseous defects in the posterolateral spine. Must be used with bone marrow aspirate. For single patient 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

• DBX® Demineralized Bone Matrix Musculoskeletal Transplant Foundation (K080399)
• DBX Strip® Musculoskeletal Transplant Foundation (K042829)
• DBX Strip® Musculoskeletal Transplant Foundation (K062205)

Submission Summary (Full Text)

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K110003

OCT 1 3 2011

## VII. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS (Per 21 CFR 807.92)

#### General Company Information

| Name: | Musculoskeletal Transplant Foundation |
|----------------------------|-------------------------------------------------------------------------------------------------|
| Contact: | Nancy Joy<br>Senior Regulatory Affairs Submission Specialist |
| Address: | 125 May Street<br>Edison, NJ 08837 USA |
| Telephone: | [phone] |
| Fax: | [phone] |
| Date Prepared | December 23, 2010 |
| General Device Information | |
| Product Name: | The MTF New Bone Void Filler |
| Classification: | Bone Void Filler Containing Human Bone<br>21 CFR §888.3045 – Product code: MBP, MQV<br>Class II |
| Predicate Devices | |

DBX® Demineralized Bone Matrix Musculoskeletal Transplant Foundation 510(k) K080399

DBX Strip® Musculoskeletal Transplant Foundation 510(k) K042829, K062205

#### Osteoinductive Potential

The MTF New Bone Void Filler is osteoconductive and has been shown to have osteoinductive potential in an athymic mouse model. Every lot of final product is tested to ensure the osteoinductive potential of the final product. Standard testing performed in an athymic mouse model must prove positive for lot release. It is unknown how the osteoinductive potential, measured in the athymic mouse model, will correlate with clinical performance in human subjects.

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#### Description

The MTF New Bone Void Filler is processed human bone that has been demineralized and combined with gelatin and sodium hyaluronate, which are naturally derived materials that are biocompatible and biodegradable. The sodium hyaluronate used in the manufacturing of the MTF New Bone Void Filler is not of animal origin. The MTF New Bone Void Filler comes in the form of a mixture of demineralized bone with gelatin and sodium hyaluronate, and a spatula that is necessary to mix the components. A hydrating agent can be used with the MTF New Bone Void Filler. Upon addition of a hydrating agent, the MTF New Bone Void Filler will achieve a flowable or moldable consistency. The resultant putty can then be manipulated by a surgeon into various shapes for ease and flexibility of use during surgical application.

### Intended Use (Indications)

The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. It is for use in the posterolateral spine only, for posterolateral spine fusions. The MTF New Bone Void Filler must be used in the spine with bone marrow aspirate.

The MTF New Bone Void Filler is for single patient use only.

### Viral Clearance and Inactivation

A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses. The BVF process further reduces the risk of viral contamination beyond donor testing and screening procedures.

#### Substantial Equivalence .

This submission supports the position that the MTF New Bone Void Filler is substantially equivalent to a number of previously cleared devices, including:

DBX® Demineralized Bone Matrix - Musculoskeletal Transplant Foundation [K080399] DBX Strip® - Musculoskeletal Transplant Foundation [K042829, K062205]

When comparing the MTF New Bone Void Filler to its predicate devices, there are no new types of safety and effectiveness questions. The MTF New Bone Void Filler has been demonstrated to be substantially equivalent to its predicate devices in the study "New Generation DBX Putty (DBM Putty III) Tested in a Rabbit Model of Posterolateral Lumbar Fusion "

## Safety and Effectiveness Information

The MTF New Bone Void Filler is single-donor processed. The MTF New Bone Void Filler is aseptically processed and passes USP <71> Sterility Tests. The MTP Trieria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1270 and Part 1271 Human Tissue Intended for Transplantation.

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### Conclusion

Musculoskeletal Transplant Foundation believes that the information provided in this 510(k) submission establishes that similar legally marketed devices have been used for the same clinical applications as the MTF New Bone Void Filler. The materials from which the MTF New Bone Void Filler is fabricated have an established history of use, and the device has been tested in accordance with applicable FDA guidelines.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

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

OCT 1 3 2011

Re: K110003

Trade/Device Name: MTF New Bone Void Filler (BVF) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device
Regulatory Class: Close U Regulatory Class: Class II Product Code: MQV, MBP Dated: October 5, 2011 Received: October 6, 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 Devices marketed in interstate
devices that have been reclassified in accordance with the Medical Device Ame devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, Inc.
and Cosmetic Act (Act) that do not require approvisions of the Federal F and Cosmetic Act (Act (Act that do not require approval of the Federal Food, Drug,
You may, therefore, market the device, subject to the seems You may, therefore, market the device, subject to the general oontrols provisions of PMA).
general controls provisions of the Act include requirements provisions of the Act. general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misting and adulteration.

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 resultations of may be subject to additional controls. Existing major regulations affectives your device care in (PMA)
found in the Code of Federal Repulations Title 2 , Regulations affect 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 ather requirements of t or any Federal statute and regulations administered by other requirements of f
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); medical do: registration and l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting and listing);
device-related adverse events) (21 CFR Part 801); medical device reporting of med device-related adverse events) (21 CFR 803); good manufacturing of medical (2006)
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Ms. Nancy Joy

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/CDRH0ffices/ucm115809.html for the Center for Devices and Badiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misblanding 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.fdagov/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 the many of School the [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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MTF New Bone Void Filler 510(k) Premarket Notification

# V. INDICATIONS FOR USE

510(k) Number (if known): K110003

Device Name: MTF New Bone Void Filler

Indications for Use:

The MTF New Bone Void Filler is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. The MTF New Bone Void Filler is indicated for treatment of surgically created osseous defects or osseous defects created from the traumatic injury. It is for use in the posterolateral or osserolateral spine first of control from thisions. The MTF New Bone Void Filler must be used in the spine with bone marrow aspirate.

The MTF New Bone Void Filler is for single patient use only.

Prescription Use x OR (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 \ NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110003