(62 days)
Not Found
Not Found
No
The summary describes a mechanical fixation device and makes no mention of AI or ML technology.
Yes
The device is intended to stabilize fractured bone fragments, which is a therapeutic intervention.
No
Explanation: The device is described as an "internal alignment and fixation device" for small bones, intended for stabilizing fractured or osteomized bones. Its function is to fix and align, not to diagnose a condition.
No
The device description explicitly states it is a "Threaded Fixation Pin" made of "Titanium Alloy," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for stabilizing bone fragments in patients with osteomized or fractured small bones. This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details a physical implantable device (a threaded pin/wire) used for internal fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. There's no mention of reagents, assays, or diagnostic testing.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used for mechanical support and fixation.
N/A
Intended Use / Indications for Use
The Threaded Fixation Pin is intended for patients where one of their small bones has been osteomized or fractured and the fragments are of sufficient size to place a .062 diameter threaded k-wire across to stabilize the part.
Product codes
JDW
Device Description
The proposed device, the Threaded Fixation Pin, claims substantial equivalence to currently marketed devices: the Orthopaedic Biosystems Limited Threaded Fixation Pin. and the Synthes Threaded Kirschner Wires. The Orthopaedic Biosystems Limited Threaded Fixation Pin, the Synthes Threaded Kirschner Wire, and the proposed device are available in Titanium Alloy. All of these devices function as internal alignment and fixation devices for small bones of the hand and foot and have no significant design differences.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
small bones of the hand and foot
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
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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.
Not Found
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
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
510(k) SUMMARY - Safety and Effectiveness
X982931
Threaded Fixation Pin
The proposed device, the Threaded Fixation Pin, claims substantial equivalence to currently marketed devices: the Orthopaedic Biosystems Limited Threaded Fixation Pin. and the Synthes Threaded Kirschner Wires. The Orthopaedic Biosystems Limited Threaded Fixation Pin, the Synthes Threaded Kirschner Wire, and the proposed device are available in Titanium Alloy. All of these devices function as internal alignment and fixation devices for small bones of the hand and foot and have no significant design differences.
1
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Thomas Sgarlato, DPM Sqarlato Laboratories, Inc. 250 Almendra Avenue Los Gatos, California 95030
K982931 Re: Trade Name: Threaded Fixation Pin Regulatory Class: II Product Code: JDW September 30, 1998 Dated: October 8, 1998 Received:
Dear Dr. Sqarlato:
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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 regulation may result in regulatory 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 regulations.
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Page 2 - Thomas Sgarlato, DPM
This letter will allow you to begin marketing your device as described in your 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 requlation (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.qov/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
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): ___K982931
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Threaded Fixation Pin is intended for patients where one of their small bones has been osteomized or fractured and the fragments are of sufficient size to place a .062 diameter threaded k-wire across to stabilize the part.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
bocote
(Divisi n Sian-Off Division of General Restorativ K98293 510(k) Number