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Vaccines, Blood & Biologics

BK090047 Letter

February 10, 2010

Spine Smith Partners, LLC
Attention: Robert Jones
Vice President of Research and Development
93 Red River
Austin, TX 78701

Re:        BK090047
            Trade Name: Fusionary Graft Delivery System
            Regulation Number: 21 CFR 880.5860
            Regulation Name: Piston Syringe
            Regulatory Class: II
            Product Code: FMF, LWE
            Dated: January 27, 2010
            Received: January 28, 2010

Dear Mr. Jones: 

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. 

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 

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 (800) 638-2041 or at its Internet address

If you have any questions concerning the contents of the letter, please contact Candace Jarvis,
B.S. at 301-827-5102. 

Sincerely yours, 


Celia M. Witten, PhD, MD
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research 


Indications for Use 

510(k) Number: BK090047
Device Name: Fusionary Graft Delivery System 

Indications For Use:
The Fusionary Bone Marrow Aspirate and Graft Delivery Kits include Jamshidi needles, syringes, the anti-coagulant ACD-A, a dual applicator manifold and various ancillary components.

These kits are intended to be used to aspirate bone marrow, autologous blood, plasma, or other blood components. In addition, they are designed to facilitate pre-mixing of bone graft materials with the aspirate, I.V. fluids, blood, plasma, platelet rich plasma or other specific blood component (s) as deemed necessary by the clinical use requirements.

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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