CELLPLEX TCP SYNTHETIC CANCELLOUS BONE

K031817 · Wrightmedicaltechnologyinc · MQV · Jul 17, 2003 · Orthopedic

Device Facts

• Record ID: K031817
• Device Name: CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MQV · Orthopedic
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CELLPLEX™ TCP Synthetic Cancellous Bone can be combined with autogenous bone marrow aspirate and/ or blood and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The CELLPLEX™ TCP Synthetic Cancellous Bone 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. The product resorbs and is replaced with bone during the healing process.

Device Story

CELLPLEX™ TCP Synthetic Cancellous Bone is a porous, tricalcium phosphate bone void filler; osteoconductive; trabecular structure mimics human cancellous bone. Implanted by surgeons into bony voids or gaps in extremities, spine, or pelvis; can be combined with autogenous bone marrow aspirate or blood. Device acts as a scaffold; guides 3D bone regeneration; resorbs over time as it is replaced by host bone. Used in clinical settings for repair of osseous defects.

Clinical Evidence

Bench testing only.

Technological Characteristics

Porous tricalcium phosphate bone void filler; trabecular structure with interconnected porosity; pore size 100-400 um; sterile; single-patient use.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability; defects may be surgically created or traumatic in origin.

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

• WMT-TCP Bone Graft Substitute (K022629)
• VITOSS™ Scaffold Synthetic Cancellous Bone Void Filler (K994337)

Submission Summary (Full Text)

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JUL 17 2003

Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in large, bold, black letters. Above the word, there is a handwritten code or number, "K031817". Below the word, there are three black lines that appear to be part of a logo or design element.

# 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 CELLPLEX™ TCP Synthetic Cancellous Bone.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------------------------------------------------|
| Date: | June 11, 2003 |
| Contact Person: | Ehab M. Esmail<br>Senior Manager of Regulatory Affairs<br>Phone: [phone] Fax: [phone] |
| Proprietary Name: | CELLPLEX™ TCP Synthetic Cancellous Bone |
| Common Name: | Bone Graft Substitute |
| Classification Name and Reference: | Filler, Calcium Sulfate Preformed Pellets,<br>Unclassified |
| Device Product Code and Panel Code: | MQV/87 |

## DEVICE INFORMATION

## A. INTENDED USE/ INDICATIONS

CELLPLEX™ TCP Synthetic Cancellous Bone can be combined with autogenous bone marrow aspirate and/ or blood and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The CELLPLEX™ TCP Synthetic Cancellous Bone 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. The product resorbs and is replaced with bone during the healing process.

# B. DEVICE DESCRIPTION

CELLPLEX™ TCP Synthetic Cancellous Bone is a porous calcium phosphate bone void filler made from tricalcium phosphate for the repair of bony defects. It is osteoconductive with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile for single patient use. CELLPLEX™ TCP Synthetic Cancellous Bone guides the three-dimensional regeneration of bone in the defect

#### headquarters

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK

www.wmt.com

011.49.4161.745130 Germany

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site into which it is implanted. Pores in the device range from 100 to 400 um nominally. When CELLPLEX™ TCP Synthetic Cancellous Bone is 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 the implant is bioabsorbed, bone grows into the space previously occupied by the bone graft substitute.

### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material composition, and design features of the CELLPLEX™ TCP Synthetic Cancellous Bone are substantially equivalent to the intended use, material composition, and design features of the previously cleared WMT-TCP Bone Graft Substitute (K022629). The mechanical properties of the CELLPLEX™ TCP Synthetic Cancellous Bone are substantially equivalent to the VITOSS™ Scaffold Synthetic Cancellous Bone Void Filler (K994337). The safety and effectiveness of the CELLPLEX™ TCP Synthetic Cancellous Bone is adequately supported by the substantial equivalence information, and testing results provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. The symbol on the right features three curved lines that resemble a stylized human figure.

Public Health Service

JUL 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031817

Trade Name: CELLPLEX TCP Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: June 11, 2003 Received: June 12, 2003

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 – Mr. 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/dsma/dsmamain.html

Sincerely yours,

O Marsh A. Mclennan

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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K031817

# CELLPLEX™ TCP Synthetic Bone Substitute INDICATIONS STATEMENT

CELLPLEX™ TCP Synthetic Cancellous Bone can be combined with autogenous bone marrow aspirate and/ or blood and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The CELLPLEX™ TCP Synthetic Cancellous Bone 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. The product resorbs and is replaced with bone during the healing process.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per21 CFR 801.109)

OR

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

Division of General Restorative Devices

(Division Sign-Off)

510(k) Number

Mark A. Milliman

ision Sign-O In ision of General. Restorative cad Neurologica

510(k) Number.

headquarters Wright Medical Technology, Inc.

5677 Airline Road Arlington, TN 38002

901.867.9971 phone

www.wmt.com

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK

011.49.4161.745130 Germany