AFT

K042125 · Musculoskeletal Transplant Foundation · MQV · Jul 28, 2005 · Orthopedic

Device Facts

• Record ID: K042125
• Device Name: AFT
• Applicant: Musculoskeletal Transplant Foundation
• Product Code: MQV · Orthopedic
• Decision Date: Jul 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AFT is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis. It is indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. AFT is for single patient use only.

Device Story

AFT is a bone void filler composed of human demineralized bone matrix, human nondemineralized bone, and sodium hyaluronate. Provided pre-loaded in a disposable delivery tube, it is used by surgeons to fill osseous defects in the extremities and pelvis that do not compromise structural stability. The device acts as an osteoconductive scaffold to support new bone growth. It is intended for single-patient use. Clinical benefit is derived from its ability to fill voids and facilitate bone healing in non-load-bearing applications.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and in vivo testing in an athymic mouse model to demonstrate osteoinductivity potential. Biocompatibility established through historical clinical use of materials and laboratory testing. Sterility verified per USP <71>.

Technological Characteristics

Composition: human demineralized bone matrix, human nondemineralized bone, sodium hyaluronate. Form factor: pre-loaded disposable delivery tube. Resorbable. Aseptically processed. Sterilization: USP <71> compliant.

Indications for Use

Indicated for patients requiring bone void filling in extremities and pelvis for surgically-created or traumatic osseous defects not intrinsic to bony stability. 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

• OSTEOSET
• Exactech Resorbable Bone Paste

Submission Summary (Full Text)

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JUL 2 8 2005

K042125

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| PROPRIETRY NAME: | AFT |
|-----------------------------------|---------------------------------------------------------------------------------------------|
| COMMON NAME: | Bone Void Filler Containing Human<br>Demineralized Bone Matrix (DBM) |
| PROPOSED REGULATORY<br>CLASS: | Class II |
| CLASSIFICATION<br>IDENTIFICATION: | 21 CFR §888.3045<br>Resorbable calcium salt bone void filler<br>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:

AFT is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis. It is indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. AFT is for single patient use only.

#### DEVICE DESCRIPTION:

AFT is composed of human demineralized bone matrix, human nondemineralized bone and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.

### SUBSTANTIAL EQUIVALENCE INFORMATION:

AFT shares the same function and intended use and therefore is substantially equivalent to OSTEOSET® and Exactech Resorbable Bone Paste. In vivo testing in the athymic mouse model has demonstrated that AFT materials can effectively support new bone growth in osseous defects.

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# SAFETY AND EFFECTIVENESS INFORMATION:

Biocompatibility of AFT materials has been established through their long Diocompanier of rective clinical use, further supported by laboratory testing mstory of sare and 20093. AFT is single-donor processed using aseptic techniques and is tested for sterility per current USP <71>.

## OSTEOINDUCTIVITY POTENTIAL

AFT is osteoconductive, and has been shown to have osteoinductivity potential in an athymic mouse. Every lot of final product will be tested to ensure the m an anymis a other inal product. Osteoinduction assay results in the ostcomative possible not be interpreted to predict clinical performance in human subjects.

### VIRAL CLEARANCE AND INACTIVATION

The method for processing the DBM and CBM (cortical cancellous) contained in the AFT 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. The CBM processing methods were determined to provide some viral inactivation potential for a wide range of viruses. In comparison, the CBM processing methods provided less viral inactivation potential than the DBM processing methods; therefore, the risk of disease transmission for the CBM component is greater than the DBM component. However, the risk for disease transmission for these components remains low due to the multiple safeguards employed, i.e., donor selection, laboratory testing, and material processing.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2005

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

Re: K042125

AFT Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: May 31, 2005 Received: June 3, 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 (fix 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 segmisms.

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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 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,
Mark N Allman

Mark N. Melkerson. 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

510(k) Number: K042125

Device Name: AFT

Indications for Use:

AFT is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis. AFT is indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury.

AFT is intended for single patient use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

Koy 2125

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Miller

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

510(k) Number *_*_