(400 days)
For bone fixation of foot and ankle surgery and hand surgery, following a trauma or osteotomy. Screws and washers are intended for single use only
Fusion Medical Cannulated Screw System is comprised of screws in diameters 2.0mm (length 10mm-24mm), 2.5mm (length10mm-38mm),3.0mm (10mm-38mm), 5.0mm (length 30mm-70mm), 6.5mm (length 30mm-120mm) standard bone screw. 2.0mm compression (length 20mm-24mm), 2.5mm compression (length10mm-38mm), 3.0mm compression( length 10mm-38mm), 4.0mm compression (length 22mm-56mm), 6.5mm compression (length 30mm- 120mm), 8.0mm compression (length 75mm-140mm) 9.0mm compression (length 75mm-140mm) compression screws. The Screws are made from implant quality Titanium alloy Ti6a14v. (See attachments for thread length, thread pitch and head geometry of screws.) The screws will be machine finished with a 32RMS roughness. K-wires are provided. K wires are made of 316lss. Screwdrivers, drills, and countersinks shanks are made of 17-4-ph stainless steel, condition H 900 heat treated shanks. They are quick connecting shanks that are interchangeable with the handles. Washers are provided. They are made of implant quality Ti6a14v titanium alloy. (See attachment for drawing of the washers and sizes. Depth gauges, and preparation instruments are part of the system.
The provided text is a 510(k) summary for the Fusion Medical Cannulated Screw System, which is a medical device for bone fixation. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established.
This document primarily outlines:
- Device Name: Fusion Medical Cannulated Screw System
- Intended Use: Bone fixation in foot, ankle, and hand surgery following trauma or osteotomy.
- Device Components: Descriptions of screws (various diameters and lengths, standard and compression types), K-wires, screwdrivers, drills, countersinks, and washers, including their materials.
- Predicate Device: Fusion Medical Cannulated Screw System (with Osteomed as the predicate's manufacturer, though the phrasing is a bit ambiguous as it says "Equivalence for this devise is based on similarities in intended use; material, design and operational principal to Fusion Medical Cannulated Screw System are the Osteomed"). This suggests the applicant's device is also named Fusion Medical Cannulated Screw System, and it's being compared to a predicate from Osteomed.
- FDA Determination: The FDA found the device substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested table and information based on the input text. The document is a regulatory submission approving the device based on substantial equivalence to a predicate, not a detailed study report on its performance against specific acceptance criteria.
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510(K) Summary
MAY 26 2009
Devise Proprietary Name:
Devise Common Name:
Classification Name:
Name of Submitter:
Fusion Medical Cannulated Screw System
Bone Screw
HWC. Screw. Fixation, Bone
John Riccio 1663 South Main Street Waterbury, CT 06706 Phone: (203)-823-8511 Fax: (860) 454-7562
Contact Person:
John Riccio
April 15, 2008
Date Prepared:
Summary:
This submission describes the Fusion Medical Cannulated Screw System
Indicated for:
Bone fixation of foot and ankle surgery and hand surgery, following a trauma or osteotomy. Screws and washers are for single use only,
Fusion Medical Cannulated Screw System is comprised of screws in diameters 2.0mm (length 10mm-24mm), 2.5mm (length10mm-38mm),3.0mm (10mm-38mm), 5.0mm (length 30mm-70mm), 6.5mm (length 30mm-120mm) standard bone screw. 2.0mm compression (length 20mm-24mm), 2.5mm compression (length10mm-38mm), 3.0mm compression( length 10mm-38mm), 4.0mm compression (length 22mm-56mm), 6.5mm compression (length 30mm- 120mm), 8.0mm compression (length 75mm-140mm) 9.0mm compression (length 75mm-140mm) compression screws. The Screws are made from implant quality Titanium alloy Ti6a14v. (See attachments for thread length, thread pitch and head geometry of screws.) The screws will be machine finished with a 32RMS roughness. K-wires are provided. K wires are made of 316lss. Screwdrivers, drills, and countersinks shanks are made of 17-4-ph stainless steel, condition H 900 heat treated shanks. They are quick connecting shanks that are interchangeable with the handles. Washers are provided. They are made of implant quality Ti6a14v titanium alloy. (See attachment for drawing of the washers and sizes. Depth gauges, and preparation instruments are part of the system.
Equivalence for this devise is based on similarities in intended use; material, design and operational principal to Fusion Medical Cannulated Screw System are the Osteomed
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
Public Health Service
MAY 26 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Riccio 1663 South Main Street Waterbury, Connecticut 06706
Re: K081122
Trade/Device Name: Fusion Medical Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 22, 2009 Received: May 22, 2009
Dear Mr. Riccio:
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.
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.
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Page 2- Mr. John Riccio
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Karla Buehler
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Fusion Medical Cannulated Screws
Indications for Use:
For bone fixation of foot and ankle surgery and hand surgery, following a trauma or osteotomy. Screws and washers are intended for single use only
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Overlin
(Division Sign-Off) for MPM
(Chision of Surgical, Orthopedic, and Restorative Devices
510(k) Number K081122
Page of
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.