DBX STRIP

K042829 · Musculoskeletal Transplant Foundation · MBP · Jan 13, 2006 · Orthopedic

Device Facts

• Record ID: K042829
• Device Name: DBX STRIP
• Applicant: Musculoskeletal Transplant Foundation
• Product Code: MBP · Orthopedic
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DBX® Strip is indicated as a bone void filler in the spine for the treatment of surgically created osseous voids or gaps that are not intrinsic to the stability of the bony structure. DBX Strip is indicated for use in the posterior elements of the spine for posterolateral fusion only. DBX Strip is for single patient use only.

Device Story

DBX Strip is a flat, malleable bone void filler composed of demineralized bone matrix (DBM), sodium phosphate dibasic buffer, and gelatin. It is used by surgeons in the spine to fill surgically created osseous voids or gaps that do not compromise bony stability. The device acts as an osteoconductive scaffold and has demonstrated osteoinductive potential in an athymic mouse model. It is provided in five sizes for single patient use. The device undergoes viral inactivation processing to reduce contamination risk beyond donor screening. It is intended for posterolateral fusion procedures.

Clinical Evidence

No clinical data provided. Osteoinductive potential was evaluated using an athymic mouse model; the correlation between this model and human clinical performance is unknown.

Technological Characteristics

Materials: Demineralized bone matrix (DBM), sodium phosphate dibasic buffer, gelatin. Form factor: Flat, malleable strip available in five sizes. Principle: Osteoconductive bone void filler. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring bone void filling in the spine for surgically created osseous voids or gaps not intrinsic to bony stability; specifically for posterolateral fusion in the posterior elements of the spine. 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.

Submission Summary (Full Text)

{0}------------------------------------------------

JAN 1 3 2006

K042829

# 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| PROPRIETARY NAME: | DBX® Strip |
|----------------------------|-------------------------------------------------------------|
| COMMON NAME: | Bone void filler containing human demineralized bone matrix |
| PROPOSED REGULATORY CLASS: | Class II |
| PRODUCT CODE: | MQV |
| PANEL CODE: | 87 - Orthopedic Devices |
| SPONSOR: | Musculoskeletal Transplant Foundation |

### INDICATIONS FOR USE:

DBX Strip® is indicated as a bone void filler in the spine for the treatment of surgically DDX burpes is maiouted gars that are not intrinsic to the stability of the bony structure. ercated osseous 10:48 01 geps and ...
DBX Strip® is indicated for use in the posterior elements of the spine for posterolateral fusion only.

DBX Strip® is for single patient use only.

### DEVICE DESCRIPTION:

DBX Strip® is a flat, malleable device composed of demineralized bone matrix DDX Stripe is a nat, manyate ("NaHy"), sodium phosphate dibasic buffer and gelatin ( DDNF ); Soundin 17/8/2017 is for single patient use only and is available in five sizes.

### SUBSTANTIAL EQUIVALENCE INFORMATION:

DBX Strip® was found to be substantially equivalent to the predicate devices. The safety and effectiveness is adequately supported by the substantial equivalence information and performance testing results provided within this Premarket Notification.

{1}------------------------------------------------

## OSTEOINDUCTIVITY POTENTIAL:

DBX Strip® is osteoconductive and has been shown to have osteoinductive potential in DDA Strip® is occeeded. Every lot of final product will be tested to ensure the an adiyine mouse moder. It is unknown how the osteoinductive osteonialerry potential of the mial prouse model, will correlate with clinical performance in human subjects.

### VIRAL INACTIVATION:

A panel of model potential human viruses representing various virus types, sizes, shapes, A panel of model potential namilar first inactivation testing demonstrated suitable viral and genomes were oratation method for a wide spectrum of potential human macervation pocential or the process further reduces the risk of viral contamination beyond donor testing and screening procedures.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The seal is rendered in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

Ms. Karen Hardwick Manager, Regulatory Affairs Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 08837

Re: K042829

DBX® Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MQV Dated: December 1, 2005 Received: December 2, 2005

Dear Ms. Hardwick:

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.

{3}------------------------------------------------

Page 2 -- Ms. Karen Hardwick

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.

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 vour 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,

Mark N. Mellon

ర్థాల్స్ లేని Mark N. Melkerson. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K042829

Device Name: DBX® Strip

Indications for Use:

ﺇ

199

DBX® Strip is indicated as a bone void filler in the spine for the treatment of surgically created osseous voids or gaps that are not intrinsic to the stability of the bony structure. DBX Strip is indicated for use in the posterior elements of the spine for posterolateral fusion only.

DBX Strip 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 NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number Ko42829