MODIFICATION TO BONE GRAFT SYRINGE

K062173 · Wrightmedicaltechnologyinc · FMF · Aug 23, 2006 · General Hospital

Device Facts

• Record ID: K062173
• Device Name: MODIFICATION TO BONE GRAFT SYRINGE
• Applicant: Wrightmedicaltechnologyinc
• Product Code: FMF · General Hospital
• Decision Date: Aug 23, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

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

Bone Graft Syringe functions as a manual piston syringe; used by orthopedic surgeons in clinical settings. Device aspirates bone marrow, autologous blood, plasma, or other body fluids; allows mixing of these fluids with bone graft materials; delivers resulting composite graft material to orthopedic surgical sites. Device serves as a tool for fluid management and graft delivery during orthopedic procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Piston syringe design; manual operation; materials and design features equivalent to predicate device (K023088).

Indications for Use

Indicated for aspiration of bone marrow, autologous blood, plasma, or other body fluids, and for mixing and delivery of composite bone graft materials to orthopedic surgical sites.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Bone Graft Syringe (K023088)

Submission Summary (Full Text)

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**AUG 23 2006**
*K062173*

Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a graphic of three horizontal lines that are angled downwards and slightly overlap each other. The lines appear to be thicker on the left side and taper off towards the right. There is a small "TM" symbol in the bottom right corner of the graphic.

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe m accordance with and 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the Bone Graft Syringe.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------|
| Date: | July 27, 2006 |
| Contact Person: | Wesley L. Reed |
| | Regulatory Affairs Specialist II |
| Proprietary Name: | Bone Graft Syringe |
| Common Name: | Piston Syringe |
| Classification Name and Reference: | 21 CFR 880.5860 Piston syringe - Class II |
| Device Product Code and Panel Code: | FMF/General Hospital-80 |

#### DEVICE INFORMATION

#### A. INTENDED USE

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

Additional sizes of the previously cleared Bone Graft Syringe (510(k): K023088) are being added to the current product offering. The syringe can be used for withdrawing body fluids and re-injecting the fluids and/or composite graft materials into the body.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, materials, and design features of the Bone Graft Syringe are the same as the predicate devices previously cleared for market. The safety and effectiveness of the Bone Graft Syringe is adequately supported by the substantial equivalence information provided within the Premarket Notification.

5677 Airline Road Arlinaton TN 38007

971 phone

**www.wmt.com**

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 ftalv

905.826.1600 Canada

011 33 1 45 13 24 40 France

011.49.4161.745130 Germany

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2006

Wright Medical Technology, Inc. % Mr. Wesley L. Reed Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K062173

Trade/Device Name: Bone Graft Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: July 27, 2006 Received: June 31, 2006

Dear Mr. Reed:

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. Wesley L. Reed

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,

for Pato Mz

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kob2473

#### Indications for Use

510(k) Number (if known):

Device Name: Bone Graft Syringe

Indications For Use:

The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone w 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 X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number /K062173