DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX

K040262 · Musculoskeletal Transplant Foundation · MQV · Mar 17, 2005 · Orthopedic

Device Facts

• Record ID: K040262
• Device Name: DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
• Applicant: Musculoskeletal Transplant Foundation
• Product Code: MQV · Orthopedic
• Decision Date: Mar 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DBX® Demineralized Bone Matrix is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. DBX® Putty can be used to fill bone voids in the extremities, posterolateral spine, pelvis and cranium. DBX® Paste and Mix can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.

Device Story

DBX® is a resorbable bone void filler composed of processed human cortical (Paste/Putty) or corticocancellous (Mix) bone granules combined with sodium hyaluronate (NaHA). Device is used by surgeons to fill non-structural osseous defects resulting from surgery or trauma. Product is supplied in three forms (Paste, Putty, Mix) and five sizes for single-patient use. By providing a scaffold for bone growth, the device assists in the treatment of bone voids. Osteoinductive potential is verified via in vivo assay.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and in vivo assays to evaluate osteoinductive potential.

Technological Characteristics

Resorbable bone void filler. Materials: Processed human cortical or corticocancellous bone granules mixed with sodium hyaluronate (NaHA). Available in three forms: Paste, Putty, and Mix. Five sizes available. Single-patient use.

Indications for Use

Indicated for treatment of surgically-created or traumatic osseous defects in patients requiring bone void filler in extremities, pelvis, cranium (Putty only), or posterolateral spine (Putty only). Not for use in defects intrinsic to bony structure stability. 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.

Submission Summary (Full Text)

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Kosolo Call

MAR 1 7 2005

AR 17 2005

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

| PROPRIETARY NAME: | DBX® Demineralized Bone Matrix Putty<br>DBX® Demineralized Bone Matrix Paste<br>DBX® Demineralized Bone Matrix Mix |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| COMMON NAME: | Bone Void Filler Containing Human<br>Demineralized Bone Matrix (DBM) |
| PROPOSED REGULATORY<br>CLASS: | Class II |
| CLASSIFICATION<br>IDENTIFICATION: | 21 C.F.R. §888.3045 Resorbable calcium salt<br>bone void filler device |
| PRODUCT CODE: | MQV |
| PANEL CODE: | 87 - Orthopedic Devices |
| SPONSOR: | Musculoskeletal Transplant Foundation<br>125 May Street<br>Edison, NJ 08837<br>732-661-0202 |

#### INDICATIONS FOR USE:

DBX® Demineralized Bone Matrix is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. DBX® Putty can be used to fill bone voids in the extremities, posterolateral spine, pelvis and cranium. DBX® Paste and Mix can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.

### DEVICE DESCRIPTION:

DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of processed human cortical bone; the DBX® Mix is composed of processed human corticocancellous bone. The bone granules are mixed with sodium hyaluronate ("NaHA") in varying combinations to form the DBX® Putty, Paste and Mix. All versions of DBX® are available in five sizes.

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## OSTEOINDUCTIVE POTENTIAL:

DBX® is assayed in vivo for its osteoinductive potential. Standard testing DDA = 15 assayed m etco 101 15 - 800 - 15 - 800 - 15

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines representing its wings or feathers.

MAR 1 7 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kathleen M. Laffan, RAC Regulatory Submission Specialist Musculoskeletal Tissue Foundation 125 mav Street Edison, NJ 08837

Re: K040262

DBX® Demineralized Bone Matrix Putty, Paste, and Mix Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV, GXP Dated: December 22, 2004 Received: December 23, 2004

Dear Ms. Laffan:

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 -- Kathleen M. Laffan, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manetally your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your dove premarket notification. The PDA miding of basification 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 If you desire specific advice ion your ac not the complexe note the regulation entitled, Contact the Office of Complance at (210) = 16 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 ( = 0 = 0 ( = 0 = 0 ( = 0 = 0 ( = 0 " Misoranumy by reference to premaixed notilities under the Act from the Division of Small other gelleral Information on your responser Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Consailters http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

K. Malle A. Melleman

Miriam C. Provost, Ph.D. 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

K040262 510(k) Number (if known):

DBX Demineralized Bone Matrix Putty, Paste and Mix Device Name:

Indications for Use:

DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that
and the may be and and sectors. It can be used in the: DBX is intended for use as a Deinment and and work. It can be used in the:

| Paste and Mix | Putty |
|---------------|----------------------|
| extremities | extremities |
| pelvis | posterolateral spine |
| | pelvis |
| | |

It is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.

DBX® is for single patient use only.

Prescription Use __X (Per 21 CFR 801 Subpart D) AND/OR

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

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

510(k) Num

Concurrence of ODRH, Office of Device Evaluation (ODE)

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

K040267