IGNITE BONE VOID FILLER KIT

K052913 · Wrightmedicaltechnologyinc · MQV · Nov 7, 2005 · Orthopedic

Device Facts

• Record ID: K052913
• Device Name: IGNITE BONE VOID FILLER KIT
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MQV · Orthopedic
• Decision Date: Nov 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IGNITE® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE® 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. The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.

Device Story

IGNITE® Kit combines ALLOMATRIX® Injectable Putty and a Bone Graft Syringe. Putty serves as bone void filler for non-structural skeletal defects; syringe facilitates aspiration of bone marrow, blood, or plasma and delivery of composite graft material to orthopedic surgical sites. Surgeons mix putty powder with sterile water or autologous bone marrow aspirate (BMA) using the syringe. Device used in clinical orthopedic settings. Osteoinductivity verified via in vitro human osteosarcoma cell bioassay and in vivo athymic rat muscle pouch model. Viral inactivation validated for processing method. Benefits include providing a convenient, osteoinductive graft delivery system for bone repair.

Clinical Evidence

No clinical trials presented. Evidence consists of bench testing and animal models. Osteoinductivity validated via in vitro human cell bioassay (correlation coefficient 0.850, p<0.0005) and in vivo athymic rat muscle pouch model. Viral inactivation validated using a panel of model human viruses.

Technological Characteristics

Kit contains demineralized bone matrix (DBM) and a piston-style syringe. Osteoinductive potential verified by bioassay. Viral inactivation processing applied. Syringe is a manual delivery tool. No electronic components or software.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities and pelvis) not intrinsic to structural stability, resulting from surgery or trauma. Syringe indicated for aspiration of bone marrow, blood, or plasma and delivery of graft material.

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

• ALLOMATRIX® Injectable Putty (K020895, K041168)
• Bone Graft Syringe (K023088)

Submission Summary (Full Text)

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NOV - 7 2005

Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" symbol on the left, followed by the text "WRIGHT MEDICAL TECHNOLOGY" in a serif font. There is also a handwritten "K052" on the right side of the logo.

A Wright Medical Group Company

# 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 IGNITE® Kit.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|---------------------------------------------------------------------------------------|
| Date: | October 14, 2005 |
| Contact Person: | Ehab M Esmail<br>Director, Regulatory Affairs<br>Phone: [phone] Fax: [phone] |
| Proprietary Name: | IGNITE® Kit |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Filler, calcium sulfate preformed pellets |
| Device Product Code and Panel Code: | Orthopedics/87/MOV |

# DEVICE INFORMATION

#### INTENDED USES/ INDICATIONS A.

IGNITE® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE® 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.

The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site

#### B. DEVICE DESCRIPTION

The IGNITE® product combines existing Wright Medical products into a kit configuration: ALLOMATRIX® Injectable Putty (K020895, K041168), and accessory

Image /page/0/Picture/12 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company".

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Bone Graft Syringe (K023088) with accessory components which are exempt from 510(k) requirements pursuant to 21 CFR 878.4800. The IGNITE® convenience kit provides surgeons the option of mixing the ALLOMATRIX® powder with sterile water or mixing with autologous bone marrow aspirate (BMA).

#### C. MATERIALS

The implant materials used for the IGNITE® Kit are substantially equivalent to the previously submitted and cleared ALLOMATRIX® implant materials.

#### D. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material composition, and design features of the IGNITE® Kit are substantially equivalent to the previously submitted and cleared ALLOMATRIX® product. The safety and effectiveness of the IGNITE® Kit is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.

## Osteoinductivity Potential

The DBM incorporated into IGNITE® Kits 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

IGNITE® Kit were assayed in vivo in the rat muscle pouch model- and found to be osteoinductive. Each lot of IGNITE® Kit 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 1 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 Effectiveness 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 and CBM contained in IGNITE® Kits 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.

Image /page/1/Picture/14 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the words is a horizontal line, and below that is the text "A Wright Medical Group Company".

Image /page/1/Picture/15 description: The image shows a black and white illustration of a planet, possibly Earth, with visible landmasses and cloud cover. A curved line above the planet suggests an atmospheric layer or a celestial object in the background. The overall style is reminiscent of a vintage or scientific illustration.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services (HHS) in the USA. The logo features the department's emblem, which is a stylized representation of a human figure. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

NOV - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ehab M. Esmail Director, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K052913

Trade/Device Name: IGNITE® KIT Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: October 14, 2005 Received: October 17, 2005

Dear Mr. Esmail:

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 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.

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Page 2 –Ehab. M. Esmail

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,

Signature

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: K052913

IGNITE® KIT Device Name:

Indications For Use:

IGNITE® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE® 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.

The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.

Prescription Use V (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)

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number K052913