(161 days)
Not Found
No
The device description and intended use are for a mechanical bone screw system, with no mention of AI/ML or related concepts.
No
Explanation: The device is a bone screw used for fixation and reconstruction of long bone fractures, which is a structural or mechanical function, not a direct therapeutic action.
No
Explanation: The device description states it is an "assortment of various sizes and configurations of stainless steel bone screws" intended for "fixation of long bone fractures and for long bone reconstructions." This is a therapeutic or surgical device, not one that gathers or analyzes data to make a diagnosis.
No
The device description explicitly states it is an assortment of stainless steel bone screws, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be implanted for use in the fixation of long bone fractures and for long bone reconstructions." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The device is described as "an assortment of various sizes and configurations of stainless steel bone screws." These are physical objects used in surgery.
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
This device is clearly an implantable surgical device, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.
Product codes
HWC
Device Description
The device is an assortment of various sizes and configurations of stainless steel bone screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone
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)
K792022, K792291, K921622, K924018, K931524, K940207, K960537, K961234, K962011
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 "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.
NOV 20 1997
916-342-4133 FAX: 916-343-4541
27 August 1997
K92217
510(k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Screw, fixation, bone A . Classification name: Common/usual name: Screw, bone screw, etc. Orthopedic Screw System Proprietary name:
- Zimmer, Herbert Bone B. Substantial equivalence: (K792022), Synthes Synthes, Screw Reconstructive Plates "Y" Plates (K792291), Alphatec Manufacturing, Inc., Alphatec (K921622), Screw System Compression Hip Fixation System Osteomed, M3 Lag Screw Threaded Howmedica, Fully Alta (K924018), Screw (K931524), Cancellous Bone Aesculap, (K940207), Titanium Alloy Bone Screws Kinetikos Medical, Inc., K2 Bone Screw System DePuy Advantage (K960537), DePuy, Inc, Screw System (K961234), Synthes, Fixation Synthes Sterile 7.0/7.3 mm Cannulated Screws (K962011) .
- C. Device Description: The device is an assortment of various sizes and configurations of stainless steel bone screws.
- D. Intended use: The device is intended to be
3407 Bay Avenue · Chico, California 95973 · USA
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implanted for use in the fixation of long bone fractures and for long bone reconstructions.
- characteristics: The Orthopedic E. Technological Screw System is a standardly used device consisting of various sizes and configurations of stainless steel bone screws.
Sincerely, FERGUSON MEDICAL
frauk fergue
Frank Fergušon Official Correspondent (FDA)
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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1997
Mr. Frank Ferguson Ferguson Medical 3407 Bay Avenue 95973 Chico, California
Re: K972217 Orthopedic Screw System Regulatory Class: II Product Code: HWC Dated: October 10, 1997 Received: October 15, 1997
Dear Mr. Ferguson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 device, subject to the general controls provisions of the Act.
The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of the Act. This device, if intended for use in pedicular screw fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
- The package insert must prominently state that the device 1 . is intended for the specific use(s) described in the enclosure only; and
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- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your 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 Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
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If you desire specific advice for your device 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 device, 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,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (If known): K972217
Orthopedic Screw System Device Name:
Indications For Use:
The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of General Restorative Devices 72217 510(k) Number _
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