DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX

K053218 · Musculoskeletal Transplant Foundation · MQV · Dec 28, 2006 · Orthopedic

Device Facts

• Record ID: K053218
• Device Name: DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX
• Applicant: Musculoskeletal Transplant Foundation
• Product Code: MQV · Orthopedic
• Decision Date: Dec 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DBX® 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, Paste, and Mix may be used in the extremities and pelvis. DBX® Putty may also be used in the posterolateral spine and cranium. DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® can be used with bone marrow. DBX® is intended for single patient use only.

Device Story

DBX® is a resorbable bone void filler composed of cadaveric cortical (Paste/Putty) or corticocancellous (Mix) bone granules mixed with sodium hyaluronate. Used by surgeons to fill non-structural osseous defects in extremities, pelvis, cranium, or posterolateral spine. Functions as an osteoconductive scaffold; provides osteoinductive potential. Applied intraoperatively to fill gaps; supports bone healing. Single patient use. Safety established via biocompatibility testing and viral inactivation processing. Osteoinductive potential verified via athymic mouse model or alkaline phosphatase assay.

Clinical Evidence

No clinical data provided. Evidence relies on bench testing, biocompatibility testing per ISO 10993, and in vitro/in vivo assays for osteoinductive potential. Viral inactivation potential validated using a panel of model human viruses.

Technological Characteristics

Materials: Cadaveric cortical or corticocancellous bone granules, sodium hyaluronate. Principle: Osteoconductive scaffold. Form: Putty, Paste, Mix. Sterilization: Aseptic processing. Testing: USP <71> sterility, ISO 10993 biocompatibility, athymic mouse model or alkaline phosphatase assay for osteoinductivity.

Indications for Use

Indicated for treatment of surgically created or traumatic osseous defects in patients requiring bone void fillers. Putty, Paste, and Mix indicated for extremities and pelvis; Putty additionally indicated for posterolateral spine and cranium. Putty may be used as a spine autograft extender. Compatible 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 (K040262)

Submission Summary (Full Text)

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K053218

DEC 2 8 2006

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

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

#### INDICATIONS FOR USE:

DBX® 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, Paste, and Mix may be used in the extremities and pelvis. DBX® Putty may also be used in the posterolateral spine and cranium. DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® can be used with bone marrow. DBX® is intended for single patient use only.

#### 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 cadaveric cortical bone; the DBX® Mix is composed of cadaveric corticocancellous bone. The bone granules are mixed with sodium hyaluronate (NaHy) in varying combinations to form the DBX® Putty, Paste, and Mix. DBX® Putty is available in five sizes and DBX® Paste and Mix are available in four sizes.

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### SAFTEY AND EFFECTIVENESS INFORMATION:

This 510(k) was submitted for a change in the osteoinductivity assay for DBX® Putty. The fundamental scientific technology of the modified DBX® Putty, using in vitro testing as an alternative for in vivo testing for osteoinductivity, is the same as the technology for the unmodified predicate, DBX® (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® Paste and DBX® Mix product will be assayed in vivo for osteoinductive potential. Standard testing performed in an athymic mouse must prove positive for lot release.

Every lot of final DBX® Putty product will be 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.

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:

This 510(k) was submitted for a change in the osteoinductivity assay for DBX® Putty. The fundamental scientific technology of the modified DBX® Putty, using in vitro testing as an alternative for in vivo testing for osteoinductivity, is the same as the technology for the unmodified predicate, DBX® (FDA cleared, K040262).

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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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Musculoskeletal Tissue Foundation % Nancy Bennewitz Regulatory Submission Specialist 125 may Street Edison, NJ 08837

DEC 28 2006

Re: K053218

Trade/Device Name: 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, MBP, GXP Dated: September 27, 2006 Received: September 29, 2006

Dear Ms. Bennewitz:

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, insting 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 not has 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 ss set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the sectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Nancy Bennewitz

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 Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Ombare Buchano

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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# IV. INDICATIONS FOR USE

510(k) Number (if known): K053218

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

Indications for Use:

DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the:

| Paste and Mix | Putty |
|---------------|----------------------|
| Extremities | Extremities |
| Pelvis | Pelvis |
| | Posterolateral spine |
| | Cranium |

DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® can be used with bone marrow.

DBX® 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.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sharlene Bucking

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

KIJS 3218 510(k) Number