WMT-TCP BONE GRAFT SUBSTITUTE

K022629 · Wrightmedicaltechnologyinc · MQV · Nov 5, 2002 · Orthopedic

Device Facts

• Record ID: K022629
• Device Name: WMT-TCP BONE GRAFT SUBSTITUTE
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MQV · Orthopedic
• Decision Date: Nov 5, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

WMT- TCP Bone Graft is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The WMT-TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. WMT- TCP Bone Graft Substitute can be combined with autogenous bone marrow aspirate and/or blood. The product resorbs and is replaced with bone during the healing process. The WMT- TCP Bone Graft Substitute is provided sterile for single use only and should not be resterilized.

Device Story

WMT-TCP Bone Graft Substitute is a porous, resorbable calcium phosphate implant designed for bone repair. It features a trabecular structure mimicking human cancellous bone to provide an osteoconductive scaffold. The device is packed into non-structural bony voids or gaps in the extremities, spine, or pelvis by a surgeon. It may be mixed with autogenous bone marrow aspirate or blood prior to implantation. Once placed, the material acts as a scaffold for new bone growth; it gradually resorbs as it is replaced by host bone during the healing process. The device is provided sterile for single-use only.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by materials data and bench testing results.

Technological Characteristics

Porous calcium phosphate resorbable bone graft substitute; trabecular structure; osteoconductive; provided sterile for single use.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability, resulting from surgery or 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.

Predicate Devices

• APATIGHT-TCP Bone Graft Substitute (K013966)

Submission Summary (Full Text)

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5 2002 NOV

Image /page/0/Picture/2 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" made up of three black triangles on the left side. To the right of the "W" is the company name, "WRIGHT MEDICAL TECHNOLOGY, INC." The address "5677 AIRLINE ROAD ARLINGTON, TN 38002" and phone number "901-867-9971" are printed below the company name.

# 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 WMT - TCP Bone Graft Substitute.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------------|
| Date: | August 6, 2002 |
| Contact Person: | Ehab M. Esmail<br>Manager, Regulatory Affairs |
| Proprietary Name: | WMT- TCP Bone Graft Substitute |
| Common Name: | Bone Graft Substitute |
| Classification Name and Reference: | Filler, Calcium Sulfate Preformed Pellets,<br>Unclassified. |
| Device Product Code and Panel Code: | Orthopedics/87/ MQV |

## DEVICE INFORMATION

## A. INTENDED USE

WMT- TCP Bone Graft is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The WMT-TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. WMT- TCP Bone Graft Substitute can be combined with autogenous bone marrow aspirate and/or blood. The product resorbs and is replaced with bone during the healing process.

The WMT- TCP Bone Graft Substitute is provided sterile for single use only and should not be resterilized.

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## B. DEVICE DESCRIPTION

Apatight-TCP Bone Graft Substitute is a porous calcium phosphate resorbable bone graft substitute for the repair of bony defects. Apatight is an osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Apatight-TCP Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site. When placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. filling the pores with new bone. As Apatight-TCP Bone Graft Substitute resorbs. bone grows into the space it previously occupied.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material composition, and design features of the WMT- TCP Bone Graft Substitute are substantially equivalent to the intended use, material composition. and design features of the previously submitted APATIGHT"- TCP Bone Graft Substitute (K013966).

The safety and effectiveness of the WMT- TCP Bone Graft Substitute with the expanded indication is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.

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Image /page/1/Picture/7 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of the word "WRIGHT" in a bold, sans-serif font, with a stylized triangular shape above it. Below the word "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.

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## DEPARTMENT OF HEALTH & HUMAN SERVICE

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9200 Corporate Boulevard Rockville MD 20850

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

Re: K022629

> Trade/Device Name: WMT-TCP Bone Graft Substitute Regulatory Class: Unclassified Product Code: MQV Dated: August 6, 2002 Received: August 7, 2002

Dear Mr. Esmail:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. 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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Mr. Ehab M. Esmail

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Marianne C. Barrett

ど、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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Image /page/4/Picture/0 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 on the right. The "W" is made up of three thick, black, angled lines, and the text is in a simple, sans-serif font.

A Wright Medical Group Company

# WMT-TCP Bone Graft Substitute

## INDICATIONS STATEMENT

WMT- TCP Bone Graft is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The WMT-TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. WMT - TCP Bone Graft Substitute can be combined with autogenous bone marrow aspirate and/or blood. The product resorbs and is replaced with bone during the healing process.

The WMT- TCP Bone Graft Substitute is provided sterile for single use only and should not be resterilized.

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K122627

Image /page/4/Picture/9 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a serif font. Below "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.