ALLOCRAFT DBM

K052735 · Lifecell Corp. · MBP · Dec 28, 2005 · Orthopedic

Device Facts

• Record ID: K052735
• Device Name: ALLOCRAFT DBM
• Applicant: Lifecell Corp.
• Product Code: MBP · Orthopedic
• Decision Date: Dec 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AlloCraft is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. AlloCraft can be used to fill bone voids in the posterolateral spine. It is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury. AlloCraft is intended for single patient use only.

Device Story

AlloCraft DBM is a bone graft material consisting of two components: demineralized bone matrix and an acellular dermal matrix, packaged in separate syringes. The surgeon mixes these components to create a moldable mixture. The device is placed directly into osseous defects that are not intrinsic to the stability of the bony structure, such as those in the posterolateral spine or resulting from trauma. It functions as an osteoconductive and osteoinductive bone void filler to support bone formation. Used in clinical settings by surgeons; intended for single-patient use.

Clinical Evidence

Bench testing and animal model studies were conducted. The manufacturer assessed osteoconductive and osteoinductive properties in valid animal models and established the performance of each lot of the DBM component. Results indicated the device functioned as intended with expected bone formation.

Technological Characteristics

Bone graft material consisting of demineralized bone matrix and acellular dermal matrix. Supplied in two separate syringes for mixing prior to application. Resorbable calcium salt bone void filler. No software or electronic components.

Indications for Use

Indicated for use as a bone void filler in patients requiring treatment for surgically created osseous defects or defects resulting from traumatic injury, including voids in the posterolateral spine, where the defect is not intrinsic to the stability of the bony structure.

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
• Wright Medical's AlloMatrix®
• Exactech's Resorbable Bone Paste

Submission Summary (Full Text)

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

K052735

## DEC 2 8 2005

## 510(K) SUMMARY

# LifeCell Corporation's AlloCraft™ DBM

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

LifeCell Corporation One Millennium Way Branchburg, NJ 08869

[phone] Phone: Facsimile: [phone]

Lorraine T. Montemurro Contact Person:

Date Prepared:December 14, 2005,

## Name of Device and Name/Address of Sponsor

AlloCraft™ DBM

LifeCell Corporation One Millennium Way Branchburg, NJ 08869

## Common or Usual Name

Bone graft material

#### Classification

Class II

#### Regulation Number

21 CFR §888.3045

#### Product Codes

MBP and MQV

## Classification Name

Resorbable calcium salt bone void filler

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

Musculoskeletal Transplant Foundation' ; DBX® Demineralized Bone Matrix Wright Medical's AlloMatrix® Exactech's Resorbable Bone Paste

## Intended Use / Indications for Use

AlloCraft is intended for use as bone void filler for voids or gaps that are not AlloCraft is intended for use as bone vera most can be used to fill bone
intrinsic to the stability of the bony structure. AlloCraft can be used of mitrinsic to the stability of the occiry an in licated for use in the treatment of volds in the posterolateral spiner some defects created from traumatic injury.

AlloCraft is intended for single patient use only.

### Technological Characteristics

AlloCraft, like all bone graft materials c >ntaining demineralized bone matrix, is a Affocraft, fire an bone grail mated or p aced within osseous defects that are not bone vold finer mallinary of paring structures. AlloCraft is packaged in two Intrinsit to the stability of the bony e de nineralized bone matrix and a second Separate Syringes, one contaming tresus pended in sterile saline. When mixed, the containing acchuiar dermal maxxture that can be molded or handled by the surgeon, or placed directly into the osse >us defect site.

### Performance Data

LifeCell has assessed the osteoconductive and osteoinductive properties of AlloCraft in valid animal models. The Company also establishes the AlloCraft in valid anniala nivach lot of the DBM component of AlloCraft in ostcomadel. In all instances, /11loCraft functioned as intended and the bone formation observed was as expected.

### Substantial Equivalence

AlloCraft is as safe and effective as the DBX and Allomatrix bone graft materials. AlloCraft is as sare and offeon ( uses ar d similar indications, technological AnoCraft has the same miches of operation as its predicate devices. The minor technological differences between Allot Traft and its predicate devices raise no technological afferences ectiveness. Performance data demonstrates that new issues of safety of offective as the predicate devices. Thus, AlloCraft is substantially equivalent.

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

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 stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A."

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2005

Ms. Lorraine T. Montemurro Manager, Regulatory Affairs LifeCell One Millennium Way Branchburg, New Jersey 08876

Re: K052735 S1

Trade/Device Name: AlloCraft™DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MBP, MQV Dated: December 14, 2005 Received: December 16, 2005

Dear Ms. Montemurro:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to 1125 20, 2017 11:25 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 I ou mayy are or ovisions 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.

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

Page 2 - Lorraine T. Montemurro

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 vours

Barbara Pouchot

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): ____________________________________________________________________________________________________________________________________________________

Device Name: AlloCraft™ DBM

Indications for Use:

AlloCraft is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. AlloCraft can be used to fill bone voids in the posterolateral spine. It is in licated for use in the treatment of surgically created osseous defects or oss :ous defects created from traumatic injury.

AlloCraft is intended for single patient use only

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Barbara Brechund for Ryan

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

510(k) Number k052735