(87 days)
Not Found
No
The summary describes a mechanical external fixator and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "wrist fixation device" intended for "fixation of unstable or comminuted extra-articular epiphyseal fracture of the distal radius," which directly treats a medical condition.
No
The device is an external fixator used for the treatment of fractures, not for diagnosing medical conditions.
No
The device description explicitly states it is a "radiolucent external fixator," which is a physical hardware device used for bone fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Fixano Radiofix wrist fixation device is a surgical implant used to stabilize bone fractures. It is applied directly to the patient's body to provide mechanical support and aid in healing.
The description clearly indicates its use in fixing bone fractures, which is a therapeutic and structural function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
The Fixano Radiofix wrist fixation device is intended for use in the fixation of unstable or comminuted extra-articular epiphyseal fracture of the distal radius, by compression, flexion or extension. The epiphyseal fragment must be in one single piece.
Product codes
KTT
Device Description
The device is a radiolucent external fixator capable of rotation and angulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, distal radius
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
Not Found
Key Metrics
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.
0
SEP 2 7 2001
510(K) SUMMARY
Manufacturer:
Fixano S.A. Z.A. Les Bruyeres 01960 Peronnas France
Ferquson Medical
others.
Consultant to Fixano S.A.
Single/multiple component
fixation appliances and accessories.
Submitted By:
Classification Name:
Common/Usual Name:
Proprietary Name: Radiofix
Classification Number: 21 CFR 888.3030/Procode 87 KTT
Substantial Equivalence:
Device Description:
Intended Use:
Technological Characteristics:
orthopedic Innovations Cobra External Fixator (K983881), and others.
Orthofix Non-bridging Pennig Wrist Fixator,
External fixation device, wrist fixator, and
metallic
bone
The device is a radiolucent external fixator capable of rotation and angulation.
The intended use is similar to that for other external fixators.
The Radiofix device is similar in its intended to predicate use devices and existent methodologies.
KO1 2078
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol consisting of three overlapping profiles of human faces, arranged in a way that they resemble a bird-like shape.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2001
Mr. Frank Ferguson C/o Fixano S.A. Ferguson Medical P.O. Box 12038 La Jolla, California 92039-2038
Re: K012078 Trade/Device Name: Radiofix Regulation Number: 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: II Product Code: KTT Dated: May 25, 2001 Received: July 2, 2001
Dear Mr. Ferguson:
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.
2
Page 2 – Mr. Frank Ferguson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse FDA finding of substantial equivalence of your device to a legally premaits in a classification " - 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 and 11 you dealer specific art 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 Compinatee at (201) 59 - 1 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner goneta mill 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/dsma/dsmamain.html
Sincerely yours,
Mark N. Millhusan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (If known): 《 0 / 2 0 / 2 0 7 8
Device Name: Radiofix
Indications For Use:
The Fixano Radiofix wrist fixation device is intended for use in the fixation of unstable or comminuted extra-articular epiphyseal fracture of the distal radius, by compression, flexion or extension. The epiphyseal fragment must be in one single piece.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Milkeuson
(Division Sign-Or (Division of General, Restorative Divisioniogical Devices
510(k) Number --
Prescription Use __ XX (Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________