(119 days)
Not Found
No
The description focuses on the mechanical function of the implantable device for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is used for fracture fixation, not for delivering therapy or treating a disease through direct intervention in the body's physiological processes beyond mechanical support.
No
The device is described as an "implantable device" for "fixation of unstable femoral neck fractures" and is part of "orthopedic trauma procedures." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is an "implantable device" and a "hip screw mechanism," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of unstable femoral neck fractures." This is a surgical procedure performed directly on the patient's body to stabilize a broken bone.
- Device Description: The device is described as an "implantable device to be used in orthopedic trauma procedures." It's a physical implant (screws and potentially a plate) used to mechanically fix a fracture.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health status, diagnose conditions, or monitor treatment. This device does not perform any such function.
Therefore, the Fixano D.S.S. System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is indicated for use in the fixation of unstable femoral neck fractures.
Product codes
HSB, HRS, HRS
Device Description
The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Unstable Femoral Neck Fractures is an implantable device to be used in orthopedic trauma procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral Neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "F" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The text is in a bold, sans-serif font.
916-342-4133 FAX: 916-343-4541
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MAY 2 2 1997
15 January 1997
510(k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Screw, fixation, bone, or Classification name: A. nail/plate/blade fixation, appliance, a combination, multiple component.
- Hip screw, hip pin, hip screw Common/Usual name: and plate, etc.
- Fixano D.S.S. (Double Sliding Proprietary name: Screws) System For Osteosynthesis of Unstable Femoral Neck Fractures.
- Fixano D.S.S. (Double Substantial equivalence: B. Synthes Sliding Screws) System (K954757), Dynamic Hip Screw (DHS) (K791619), Howmedica Plus Compression Hip Screw System Omega (K955306), and others.
- (Double The Fixano D.S.S. C. description: Device System For Osteosynthesis of Sliding Screws) Neck Fractures Femoral is an Unstable implantable device to be used in orthopedic trauma procedures.
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oded use: System For Intended use: D. Femoral Neck Fractures is intended for use in the fixation and osteosynthesis of unstable femoral neck fractures.
K- c-7 7-25 -
Technological characteristics: The D.S.S. System E . For Osteosynthesis of Unstable Femoral Neck Fractures is a hip screw mechanism that allows a natural, weight-bearing compression. The D.S.S. screws can be utilized alone, or in combination with a mini-plate, allowing most of osteosynthesis in flexibility configurations of unstable femoral neck fractures.
Submitted, FERGUSON MEDICAL FDA_Establishment Registration Number 2937794
Arank Foutson
Frank Ferguson Official Correspondent
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized representation of an eagle with three lines extending from its head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1997
Frank Ferquson Mr. Official Correspondent Ferquson Medical ... .. .. .. .. .. .. 3407 Bay Avenue Chico, California 95973
Re : K970257 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 Regulatory Class: II Product Codes: HSB, HRS and HRS Dated: April 15, 1997 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 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 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 requlations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in
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Page 2 - Mr. Frank Ferguson
Please note: this response to your the Federal Reqister. 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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K 9-10258 10(k) Number (If known):
Fixano DSS (Double Sliding Screw) System For Device Name: Osteosynthesis of Unstable Femoral Neck Fractures
Indications For Use:
This device is indicated for use in the fixation of unstable femoral neck fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTEHR PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) (Division of Gigh Off)
Division of General Restorative Devi 51C(k) Number -------
Over-The-Counter Use _