ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T

K040980 · Wrightmedicaltechnologyinc · MQV · Jul 14, 2004 · Orthopedic

Device Facts

• Record ID: K040980
• Device Name: ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MQV · Orthopedic
• Decision Date: Jul 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Device Story

Bone void filler kit containing premeasured powder, CBM chips, and mixing solution. Components hydrated and mixed to form putty; packed into non-structural bony voids or gaps in extremities and pelvis. Used by surgeons to fill surgically created or traumatic osseous defects. Provides scaffold for bone healing. Safety and effectiveness supported by in vitro osteoinductivity bioassays (Saos human osteosarcoma cell proliferation) and viral inactivation processing. Clinical performance evaluated via radiographic outcomes and adverse event profiles compared to predicate devices.

Clinical Evidence

Bench testing and canine model studies. In vitro bioassay (Saos cell proliferation) used to assess osteoinductivity of DBM lots, correlated with athymic rat model (r=0.850, p<0.0005) and clinical healing data. Viral inactivation potential validated using model human viruses. Canine model used to evaluate radiographic and histological performance of varying CBM concentrations. No significant differences in radiographic outcomes or adverse event profiles compared to predicate devices.

Technological Characteristics

Bone void filler composed of Demineralized Bone Matrix (DBM) and Calcium Bone Matrix (CBM) chips with a binding medium. Supplied as a kit with mixing tools. Sterile, single-patient use. Osteoinductivity assessed via cell-based bioassay. Viral inactivation achieved through material processing methods.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities and pelvis) that are not intrinsic to the stability of the bony structure. Defects may be surgically created or result from traumatic injury.

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}------------------------------------------------

K040980

# JUL 1 4 2004

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical In wees Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of ALLOMATRIX® C Putty, ALLOMATRIX® Custom Putty and ALLOMATRIX® DR Putty.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|---------------------------------------------------------------------------|
| Date: | April 12, 2004 |
| Contact Person: | Roger D. Brown<br>Sr. Director, Clinical, Regulatory & Reimbursement |
| Proprietary Name: | ALLOMATRIX® C Putty, ALLOMATRIX® Custom<br>Putty and ALLOMATRIX® DR Putty |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Filler, Calcium Sulfate Preformed Pellets - Class II<br>888.3045 |
| Device Product Code and Panel Code: | Orthopedics/MOV |

### DEVICE INFORMATION

#### INTENDED USE A.

ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

#### DEVICE DESCRIPTION B.

ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products come in the form of a kit with a premeasured powder and CBM chips, premeasured mixing solution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.

#### SUBSTANTIAL EQUIVALENCE INFORMATION ﺯ

ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products were found to be substantially equivalent to the predicate devices. The safety and effectiveness of ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.

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

### Osteoinductivity Potential

Ostomation incorporated into the ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products is assayed in vitro for its osteoinductive potential. The bioassay measures the proliferation of Saos human osteosarcoma cells in the presence of human DBM compared to positive and negative controls (osteoinductivity index). Results from the bioassay were correlated with results from implantation of DBM into athymic rat muscle', which demonstrated a correlation coefficient of 0.850 (p<0.0005) and accurately predicted the in vivo osteoinductivity of 99 of 101 donor lots. Additionally, clinical results using DBM with >0.20 and ≤0.20 demonstrated a significant difference in healing as evaluated by radiography, 92% and 33% healing, respectively.3

Each lot of DBM incorporated into ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putties is evaluated in vitro using a surrogate cell-based assay'. The bioassay measures the proliferation of Saos human osteosarcoma cells in the presence of human DBM compared to positive and negative controls (osteoinductivity index)'. Results from this bioassay were correlated to the athymic rat model and to clinical results of assayed DBM alone 3 Testing each lot of DBM with this cell-based bioassay assures that only DBM with osteoinductive potential is used in the ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putties. The combination of DBM, CBM and binding medium has not been evaluated for osteoinductivity; therefore, it is unknown to what extent the formulation components may alter the osteoinductive character of the DBM. Additionally, it is unknown how osteoinductivity of the DBM component, measured via the in vitro bioassay', will correlate with human clinical performance of ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putties.

- Wilkins, R.M. (1999) Clinical Effectiveness of Demineralized Bone Matrix Assayed in Human Cell l Culture, Advances in Tissue Banking. 3:113-124
- Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in compositive 2 grafts of bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug;(150):288-300. Note: The product is considered osteoinductive if one specimen (explant) contains new bone (i.e. bone occupied with lamellae), cartilage, and/or chondrocytes.
- Data on file at Wright Medical Technology, Inc. 3

### Viral Inactivation Potential

The method for processing the DBM and CBM contained in the ALLOMATRIX® C, ALLOMATRIX® Custom and ALLOMATRIX® DR Putty Products 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 for disease transmission from the CBM component is greater than the DBM component. However, the risk of disease transmission for these components remains low due to the multiple safeguards employed, i.e., donor selection, laboratory testing, and material processing.

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

### Product Performance Testing

I roduct I clinical performance was evaluated by a comparison of radiographic outcomes and the adverse event profiles compared to the predicate devices. There were no significant differences in the radiographic outcomes or adverse event profiles of the ALLOMATRIX® C, attrereless in the radiographic Sul OMATRIX® DR Putty Products and the predicate devices.

Performance of DBM putty formulations that included varying amounts of CBM were evaluated in a canine model by radiographic and histological methods.

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

Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus symbol with three lines representing the human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

JUL 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger D. Brown Director, Regulatory Affairs Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002

Re: K040980

Allomatrix C. Allomatrix Custom and Allomatrix DR Putty Products Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: April 14, 2004 Received: April 15, 2004

Dear Mr. Brown:

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 vour 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

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

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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark A. Millburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# INDICATIONS FOR USE

510(K) Number (if known):_K_040980

ALLOMATRIX® C Putty, ALLOMATRIX® Custom Putty and Device Name: ALLOMATRIX® DR Putty

Indications for Use:

ALLOMATRIX® C Putty, ALLOMATRIX® Custom Putty and ALLOMATRIX® DR Putty are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. multicated only 10. 8011 10.13 0. gaps TRIX® Custom Putty and ALLOMATRIX® DR Putty are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Prescription Use _ X (Per21 CFR 801.109) OR

Over-The Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mulkerson

Division of General, Restorative, and Neurological Devices

510(k) Number K040980