(68 days)
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No
The summary describes a mechanical screw system for joint fixation and does not mention any software, image processing, or AI/ML terms.
Yes
The device is intended for fixation arthrodesis of various joints, which is a therapeutic intervention to fuse bones for stability and pain relief.
No
Explanation: This device is a screw system intended for fixation arthrodesis of various joints, which is a therapeutic rather than a diagnostic function. It is used for treatment, not diagnosis.
No
The device description and performance studies clearly indicate this is a hardware device (screw system) used for fixation, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a screw system) intended for fixation arthrodesis (a surgical procedure to fuse joints) in specific anatomical locations within the extremities. This is a device used within the body during a surgical procedure, not a device used to test samples outside the body.
The information provided aligns with a typical submission for a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
"The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints."
Product codes
HWC
Device Description
The EXTREMITY MEDICAL Screw System
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing, including pull-out strength and torque was performed and compared to the predicate devices. Clinical simulations in cadavers were performed to verify the surgical technique. No clinical testing was performed.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Special 510(k) Summary of Safety and Effectiveness:
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