ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM

K041663 · Wrightmedicaltechnologyinc · MQV · Sep 16, 2004 · Orthopedic

Device Facts

• Record ID: K041663
• Device Name: ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MQV · Orthopedic
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2

Intended Use

ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP, and ALLOMATRIX® PLUS CBM are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM 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

ALLOMATRIX® products (TCP, CaSO4 filled TCP, and PLUS CBM) are bone void fillers supplied as kits containing premeasured powder, TCP/CBM chips, and mixing solution. Clinicians mix components to create a putty, which is then manually packed into non-structural bony voids or gaps in the extremities or pelvis. The device acts as a scaffold for bone repair. It is intended for single-patient use in a surgical setting. The product incorporates demineralized bone matrix (DBM) processed for viral inactivation and assayed for osteoinductive potential.

Clinical Evidence

No human clinical data provided. Performance evaluated via bench testing and a canine model using radiographic and histological methods. Viral inactivation validation performed using a panel of model human viruses.

Technological Characteristics

Bone void filler kit containing TCP, CaSO4, and DBM/CBM components. Supplied sterile for single-patient use. Materials include TCP, CaSO4, and DBM. No electronic or software components.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in the skeletal system (extremities and pelvis) that are 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.

Submission Summary (Full Text)

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K041663 1/2

# SEP 1 6 2004

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe in accordance with the Food and Drag Formance with 21 CRF 807, this information serves as a
Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information o Medical Devices Act of 1970 and in ven the use of ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP, and ALLOMATRIX® PLUS CBM.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|----------------------------------------------------------------------------------|
| Date: | September 15, 2004 |
| Contact Person: | Brian Young<br>Director, Regulatory Affairs |
| Proprietary Name: | ALLOMATRIX® TCP, ALLOMATRIX® w/<br>CaSO4 Filled TCP, and ALLOMATRIX® PLUS<br>CBM |
| 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/MQV |

### DEVICE INFORMATION

#### INTENDED USE A.

INTENDED USE ADDOMIXTRIA - 15-15-14-11-11-11-11-11-11-11-11-11-11-11-11-11-11-11-2017-11-11 of the bony structure. ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM 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.

DEVICE DESCREAT TOT!
ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM come in the form of a kit with a premeasured powder, TCP and/or CBM chips, premeasured mixing solution, and the tools necessary to mix the components. emps, premeasured himmy 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.

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K041663

### C. SUBSTANTIAL EQUIVALENCE INFORMATION

ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM were found to be substantially equivalent to the predicate devices. The safety and effectiveness of ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.

#### Osteoinductivity Potential

Each lot of DBM incorporated into ALLOMATRIX® TCP, ALLOMATRIX® with CaSO4 Filled TCP and ALLOMATRIX® Plus CBM (hereafter ALLOMATRIX® Putty Products) is assayed in vitro for a native protein as a surrogate test marker for osteoinductive potential. Results from this immunoassay were correlated to the athymic rat model for the DBM alone and the ALLOMATRIX Putty Products.2 Testing each lot of DBM with this immunoassay assures that only DBM with osteoinductivity potential is used in the ALLOMATRIX® Putty Products. Although only one native protein is used as the test marker, it is the combination of various proteins in the DBM that is responsible for its osteoinductivity potential. The combination of DBM, 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 potential. measured by this surrogate immunoassay, will correlate with human clinical performance of the Allomatrix Putty Products.

- l Data on file at Wright Medical Technology, Inc.
- 2 Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in compositive grafts of bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug;(150):288-300.

#### Viral Inactivation Validation

The method for processing the DBM and CBM contained in ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM 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 viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses.

#### Product Performance Testing

Performance of ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM were evaluated in a canine model by radiographic and histological methods.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an emblem of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

Mr. Brian J. Young Director, Regulatory Affairs Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002

Re: K041663

ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP, and ALLOMATRIX® PLUS CBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: June 14, 2004 Received: June 18, 2004

Dear Mr. Young:

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 macketed 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 aqencies. 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 pregetive

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Page 2 - Mr. Brian J. Young

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/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

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

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## INDICATIONS FOR USE

510(K) Number (if known):_K04 (663

ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and Device Name: ALLOMATRIX® PLUS CBM

Indications for Use:

ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP, and ALLOMATRIX® PLUS CBM are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM 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)

Muriam C. Provost

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

K041663 510(k) Number_