(62 days)
The SBI Hand Fixation System™ is a system of plates and screws that is intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.
The SBI Hand Fixation System™ consists of a series of stainless steel plates and screws of varying lengths and thicknesses and is provided in various configurations, including straight, T-, Y-, Z-, compression L-, compression T-, and compression Y-plates. These plates are attached to bone via 1.5, 1.7, 2.0, 2.2, 2.4, and 2.6mm self tapping cortex screws.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study details that would allow me to populate the requested table and answer your questions. The document is a 510(k) summary and the FDA's response letter for the SBI Hand Fixation System, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance data or study methodology.
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K050462 p'/1
APR 2 6 2005
510(k) Summary
| Manufacturer: | Small Bone Innovations1711 S. Pennsylvania AvenueMorrisville, PA 19067 |
|---|---|
| Submitted By: | Mr. Donald W. Guthner, Vice PresidentMusculoskeletal Clinical Regulatory Advisers505 Park Avenue, 14th FloorNew York, NY 10022dguthner@mcrallc.com212-586-0250 - Office212-750-2112 - Fax |
| Proprietary Name: | SBI Hand Fixation System™ |
| Classification name: | Class II, 888.3030 - Plate, Fixation, Bone, Non-SpinalClass II, 888.3040 - Screw, Fixation, Bone, Non-Spinal |
| Common/Usual Name: | Internal Fixation System |
| Substantial Equivalence: | Documentation is provided which demonstrated the (name)to be substantially equivalent to other legally marketeddevices. |
| Device Description: | The SBI Hand Fixation System™ consists of a series ofstainless steel plates and screws of varying lengths andthicknesses and is provided in various configurations,including straight, T-, Y-, Z-, compression L-, compressionT-, and compression Y-plates. These plates are attached tobone via 1.5, 1.7, 2.0, 2.2, 2.4, and 2.6mm self tappingcortex screws. |
| Intended Use: | The SBI Hand Fixation System™ is a system of plates andscrews that is intended for use in selective trauma,reconstructive procedures, and general surgery of the hand,wrist, and other small bones. |
| Material: | 316L Stainless Steel |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight, arranged in a layered or overlapping manner.
Public Health Service
APR 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations LLC C/o Mr. Donald Guthner Vice President Musculoskeletal Clinical Regulatory Advisers, LLC 505 Park Avenue, 14th Floor New York, New York 10022
Re: K050462
Trade/Device Name: SBI Hand Fixation System™ Regulation Number: 21 CFR 888.3030, 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: February 22, 2005 Received: February 23, 2005
Dear Mr. Guthner:
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. Donald Guthner
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name:_SBI Hand Fixation System™
Indications For Use:
The SBI Hand Fixation System™ is a system of plates and screws that is intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.
Prescription Use V (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)
tive
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.