(21 days)
Not Found
No
The summary describes a fusion or fracture fixation device for the great toe joint, which is a mechanical implant. There is no mention of image processing, AI, ML, or any software-driven analytical capabilities.
No
The device is described as a fusion or fracture fixation device. While it aids in recovery, it is a structural support device rather than a device that delivers therapy (e.g., medication, radiation, or electrical stimulation).
No
Explanation: The device is indicated as a fusion or fracture fixation device, not for diagnosis.
No
The device description explicitly states it is a "fusion or fracture fixation device," which are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "fusion or fracture fixation device for the IP joint of the great toe." This describes a surgical implant used to stabilize bones, which is a medical device, not a diagnostic test performed on samples outside the body.
- Device Description: The description reinforces that it's a physical implant ("scalar version indicated for the IP joint of the great toe").
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical and structural within the body.
N/A
Intended Use / Indications for Use
StayFuse GT-IP is indicated as a fusion or fracture fixation device for the IP joint of the great toe.
Product codes (comma separated list FDA assigned to the subject device)
87HWC
Device Description
StayFuse GT-IP has identical design features as the original StayFuse™, as such, GT-IP is a scalar version indicated for the IP joint of the great toe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
IP joint of the great toe
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): 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.
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
§ 888.3040 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.
0
StayFuse GT-IP K 022726 510(k) Premarket Notification Summary
Demonstrating Substantial Equivalence to StayFuse™ K990804 August 12, 2002
Manufacturer Identification and Sponsor
Pioneer Surgical Technology 375 River Park Circle Marquette, MI 49855-1781 Telephone: 906-226-9909 906-226-4455 Fax:
Official Contact: Kathy Moran, Manager Regulatory Affairs Establishment Registration Number: 1833824
Device Identification
Proprietary Name: StayFuse GT-IP Common Name: StayFuse GT-IP Regulation Number: 888.3040, Class II Classification Number: 87HWC
Substantial Equivalence:
Proprietary Name and original 510(k): StayFuse™; K990804 Common Name: StayFuse™ Regulation Number: 888.3040, Class II Classification Numbers: 87HWC
Device Description
StayFuse GT-IP has identical design features as the original StayFuse™, as such, GT-IP is a scalar version indicated for the IP joint of the great toe.
Technological Comparison
Pioneer Surgical Technology's StayFuse GT-IP is substantially equivalent to the unmodified StayFuse™ device. There are no different technological characteristics between the new device and the cleared device except for physical size.
Indications for Use
StayFuse GT-IP is indicated as a fusion or fracture fixation device for the IP joint of the great toe.
Intended Use
StayFuse GT-IP is a screw device designed to stabilize and hold small bones in alignment during the healing process. StayFuse GT-IP is indicated as a fusion or fracture fixation device for the IP joint of the great toe.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 6 2002
Ms. Kathy Morgan
Manager of Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855
Re: K022726
Trade/Device Name: StayFuse GT-IP Regulation Number: 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulation Class: II Product Code: HWC Dated: August 12, 2002
Received: August 16, 2002
Dear Ms. Morgan:
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 - Ms. Kathy Morgan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small 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,
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
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510(k) NUMBER (IF KNOWN) : K022726
DEVICE NAME: StayFuse GT-IP
INDICATIONS FOR USE :
StayFuse GT-IP is indicated as a fusion or fracture fixation device for the IP joint of the great toe.
:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ___ (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Stip Dwork
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________