ALLOMATRIX MODEL# 86

K020895 · Wrightmedicaltechnologyinc · MQV · Mar 5, 2004 · Orthopedic

Device Facts

• Record ID: K020895
• Device Name: ALLOMATRIX MODEL# 86
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MQV · Orthopedic
• Decision Date: Mar 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ALLOMATRIX® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® Putty is 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® Putty is a bone void filler kit consisting of human demineralized bone matrix (DBM), calcium sulfate, and carboxymethylcellulose. Supplied as a kit with premeasured powder and mixing solution; clinician hydrates powder to form a putty. Used in clinical settings to fill non-structural bony voids or gaps in the extremities and pelvis resulting from surgery or trauma. The putty is packed into the defect site. The device is osteoinductive, with each lot assayed in an athymic rat muscle pouch model to ensure biological activity. Benefits include providing a scaffold for bone healing. Safety is supported by viral inactivation validation and comparative radiographic/histological performance testing.

Clinical Evidence

Evidence includes in vitro bioassays (Saos human osteosarcoma cell proliferation) and in vivo rat muscle pouch models to confirm osteoinductivity. Canine model testing evaluated radiographic and histological performance. Clinical performance was assessed via comparison of radiographic outcomes and adverse event profiles against the predicate device, showing no significant differences.

Technological Characteristics

Combination device: human demineralized bone matrix (DBM) with calcium sulfate and carboxymethylcellulose binding medium. Supplied sterile for single-patient use. Form factor is a hydrated putty. No electronic components or software.

Indications for Use

Indicated for bony voids or gaps in the skeletal system (extremities and pelvis) not intrinsic to structural stability. Suitable for surgically created or traumatic osseous defects.

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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MAR - 5 2004

K020895

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices 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® Putty.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|------------------------------------------------------------------|
| Date: | February 16, 2004 |
| Contact Person: | Roger D. Brown<br>Sr. Director, Clinical and Regulatory Affairs |
| Proprietary Name: | ALLOMATRIX® 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/MQV |

### DEVICE INFORMATION

### A. INTENDED USE

ALLOMATRIX® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® Putty is 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® Putty is a combination of Human Demineralized Bone Matrix (DBM) with a binding medium of calcium sulfate and carboxymethylcellulose.

ALLOMATRIX® Putty comes in the form of a kit with a premeasured powder, premeasured mixing sclution, 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.

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#### SUBSTANTIAL EQUIVALENCE INFORMATION ﻧ

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

### Osteoinductivity Potential

The DBM incorporated into ALLOMATRIX® Putty 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 muscle2, 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

ALLOMATRIX® Putty was assayed in vivo in the rat muscle pouch model2 and found to be osteoinductive. Each lot of ALLOMATRIX® Putty is assayed in vivo in the athymic rat muscle pouch to ensure the osteoinductivity potential of the final product.

- Adkisson HD, Strauss-Schoenberger J, Gillis M, Wilkins R, Jackson M, and Hruska KA. Rapid Quantitative Bioassay of Osteoinduction, J Ortho Res, 2000, 18:503-511.
- Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in composite grafts of 2 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.
- 3 Wilkins RM. Clinical Iffectiveness of Demineralized Bone Matrix Assayed in Human Cell Culture, Advances in Tissue Banking. 1999 3:113-124

### Viral Inactivation Validation

The method for processing the DBM contained in ALLOMATRIX® Putty 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

Evaluation of clinical performance was evaluated by a comparison of radiographic outcomes and the adverse event profiles compared to the predicate device. There were no significant differences in the radiographic outcomes or adverse event profiles of ALLOMATRIX® Putty and the predicate device.

Performance of ALLOMATRIX® Putty was evaluated in a canine model by radiographic and histological methods.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 2004

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

Re: K020895 Trade Name: ALLOMATRIX® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: January 6, 2004 Received: January 7, 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 (sec 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 cquivalence determination does not mcan 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

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Page 2 - Mr. Roger D. Brown

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice in and listing (21 CFR Part 607), laoolity systems (QS) regulation (21 CFR Part 820); and if requirents as sectionic 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 This letter will anow you to ough managers of substantial equivalence of your device 510(K) prematice notification "Invice 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), If you desire specific ad ree for your as 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 may obtain other generational 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,

[signature]

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):__K020895________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

ALLOMATRIX® Putty is indicated only for bony voids or gaps that are not intrinsic to the ALLOMATRIX - Fatty is indicated only 10 000 000 is intended to be gently packed into bony stablify of the bolly stractal system (i.e., the extremities and pelvis). These defects may be volus of gaps of the skeletar of each (trom traumatic injury traumatic injury to the bone.

Prescription Use _ X (Per21 CFR 801.109)

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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)

K020895

Division of General, Restorative, and Neurological Devices

510(k) Number K020855