(119 days)
This device is indicated for use in the fixation of subtrochanteric fractures.
The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub-Trochanterian Fractures is an implantable device be used in orthopedic trauma to procedures.
This appears to be a 510(k) premarket notification for a medical device called the "Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub-Trochanterian Fractures." This documentation focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study to prove acceptance criteria based on detailed performance metrics.
Therefore, the provided text does not contain the information requested to describe acceptance criteria and a study that proves the device meets those criteria. Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Details about a specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on MRMC studies or standalone algorithm performance.
- Information on training set sample size or how its ground truth was established.
This document is a regulatory submission demonstrating substantial equivalence, not a clinical or performance study report.
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Image /page/0/Picture/1 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "M" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The logo is black and white and has a bold, modern look.
MAY 2 2 1997
916-342-4133 FAX: 916-343-4541
15 January 1997
510(k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Screw, fixation, bone, or A. Classification name: nail/plate/blade fixation, appliance, combination, multiple component.
- Hip screw, hip pin, hip screw Common/Usual name: and nail, etc.
- Fixano D.S.S. (Double Sliding Proprietary name: For Osteosynthesis of Sub-Screws) System Trochanterian Fractures.
- Fixano D.S.S. (Double Substantial equivalence: B. Sliding Screws) System (K954757), Howmedica Alta CFX IM Rod System (K960524), Howmedica Gamma Locking Nail (K932174), Howmedica Gamma Locking Nail -- Long Length (K944883), and others.
- The Fixano D.S.S. (Double C. Device description: System For Osteosynthesis of Sliding Screws) Sub-Trochanterian Fractures is an implantable device be used in orthopedic trauma to procedures.
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D.S.S. System For The Intended use: D. Osteosynthesis of Sub-Trochanterian Fractures is intended for use in the fixation and osteosynthesis of sub-trochanterian fractures.
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cal characteristics: Technological characteristics: E. For Fractures is a hip D.S.S. sliding screws in utilizes the combination with an intramedullary nail. This in for maximum stability the allows sub-trochanterian osteosynthesis of most fractures.
Submitted, FERGUSON MEDICAL FDA_Establishment Registration Number 2937794
FDA Establishment Registration Number
Frank Ferguson
Official Correspondent
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with stylized wings. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1997
Mr. Frank Ferguson Official Correspondent Ferguson Medical 3407 Bay Avenue 95973 Chico, California
K970257 Re : Fixano Double Sliding Screws (D.D.S.) with Intramedullary Nail K970258 Fixano Double Sliding Screws (D.D.S.) and Mini-Plate K970280 Fixano Double Sliding Screws (D.D.S.) and Sid Plate Requlatory Class: II Product Codes: HSB, HRS and HRS April 15, 1997 Dated: Received: April 21, 1997
Dear Mr. Ferguson:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, subject to the general controls The general controls provisions of the provisions of the Act. Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਮੈਂ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your devices in
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Page 2 - Mr. Frank Ferquson
this response to your Please note: the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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KG7702257 i10(k) Number (If known):
Fixano DSS (Double Sliding Screw) System For Device Name: Osteosynthesis of Sub-Trochanterian Fractures
Indications For Use:
This device is indicated for use in the fixation of subtrochanteric fractures.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
toate
(Division Signi-Off) -Division of General Restorative De 510(k) Number .
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.