BONE GRAFT SYRINGE, MODEL 8600-00X0

K023088 · Wrightmedicaltechnologyinc · FMF · Oct 2, 2002 · General Hospital

Device Facts

• Record ID: K023088
• Device Name: BONE GRAFT SYRINGE, MODEL 8600-00X0
• Applicant: Wrightmedicaltechnologyinc
• Product Code: FMF · General Hospital
• Decision Date: Oct 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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 manual piston syringe; consists of calibrated hollow barrel and movable plunger with male connector nozzle for needle attachment. Used by orthopedic surgeons in surgical settings to aspirate body fluids (bone marrow, blood, plasma); mix aspirated fluids with bone graft materials; and deliver resulting composite graft to surgical site. Device facilitates preparation and application of bone graft materials during orthopedic procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparisons.

Technological Characteristics

Piston syringe design; calibrated hollow barrel and movable plunger; male connector nozzle for single lumen needle attachment. Manual operation; no energy source. Materials and specifications not detailed beyond general piston syringe classification (21 CFR 880.5860).

Indications for Use

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

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.

Submission Summary (Full Text)

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OCT 02 2002

Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" made up of three thick, black, angled bars. To the right of the "W" is the text "WRIGHT MEDICAL TECHNOLOGY" stacked in three lines. The word "WRIGHT" is on the top line, "MEDICAL" is on the second line, and "TECHNOLOGY" is on the third line.

# 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 use of the Bone Graft Syringe.

| Submitted By: | Wright Medical Technology, Inc. |
|------------------------------------|-----------------------------------------------------------------|
| Date: | May 15, 2002 |
| Contact Person: | Roger D. Brown<br>Sr. Director, Clinical and Regulatory Affairs |
| 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: | 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

The syringe consists of a calibrated hollow barrel and a movable plunger. At the distal end of the syringe there is a male connector nozzle for fitting the female connector (hub) of a single lumen needle. The syringe can be used for withdrawing body fluids and reinjecting 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 substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of the Bone Graft Syringe are adequately supported by the substantial equivalence information provided within the Premarket Notification.

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Public Health Service

OCT 02 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. c/o Mr. Mark Job TÜV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891

Re: K023088

Trade/Device Name: Bone Graft Syringe Regulation Number: 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: September 13, 2002 Received: September 17, 2002

Dear Mr. Job:

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 mav 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. Mark Job

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 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 yours,

At Rwd

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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K023 of

Image /page/3/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the text "WRIGHT MEDICAL TECHNOLOGY" on the right. The text is stacked in three lines, with "WRIGHT" on the top line, "MEDICAL" on the second line, and "TECHNOLOGY" on the third line.

A Wright Medical Group Company

## BONE GRAFT SYRINGE

### INDICATIONS STATEMENT

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.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE: QN ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per21 CFR 801.109) √

(Division Sign-Off) . Division of General Restorative Devices 510(k) Number

OR

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

Atgt Rhode

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

KOLSO88 510(k) Number _