(119 days)
Not Found
No
The summary describes a mechanical implant for fracture fixation and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as an "implantable device" for "fixation of subtrochanteric fractures" and "osteosynthesis," indicating it is used to structurally support healing bones rather than to treat or cure a disease or condition itself.
No
Explanation: The device is an implant for fracture fixation, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is an "implantable device," which is a hardware component, 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 "fixation of subtrochanteric fractures." This describes a surgical procedure performed directly on a patient's body to stabilize a broken bone.
- Device Description: The device is described as an "implantable device be used in orthopedic trauma to procedures." This further confirms it's a surgical implant used within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The provided description does not mention any such use or interaction with biological specimens.
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 subtrochanteric fractures.
Product codes (comma separated list FDA assigned to the subject device)
HSB, HRS
Device Description
The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub-Trochanterian 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
Sub-Trochanterian (fractures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic trauma
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K954757, K960524, K932174, K944883
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K 9 7 0 2 5 7
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.
1
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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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- 7 - 2 - 7 - 2 -
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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
2
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTEHR PAGE IF NEEDBD)
Concurrence of CDRH, Office of Device Evaluation (ODE)
toate
(Division Signi-Off) -Division of General Restorative De 510(k) Number .