(89 days)
The (Linvated) Concept 6.5mm Screw and Spiked Washer Anchoring Implant
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No
The device description and intended use focus on mechanical components for surgical repair, with no mention of AI/ML capabilities or data processing.
Yes
The device is described as a Ligament Anchor system used to repair damaged anterior and posterior cruciate ligaments, which aims to provide relief of pain and restoration of knee function, indicating a therapeutic purpose.
No
The device is described as a system for repairing damaged ligaments by securing tendons to bones, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines a system of physical implants (Ligament Anchors, Ligament Staples, Bone Screws) and a surgical instrument (Ligament Claw Impactor) made from titanium. There is no mention of software as a component or the primary function of the 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, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Description: The provided text describes a system of implants (Ligament Anchors, Ligament Staples, Bone Screws) and an instrument (Ligament Claw Impactor) that are surgically implanted into the patient's body to repair damaged ligaments.
- Intended Use: The intended use is to secure tendons to bone within the patient's body to reconstruct ligaments.
The device is a surgical implant system used for orthopedic repair, not for testing biological samples in a lab.
N/A
Intended Use / Indications for Use
For use in conjunction with the patient's medial hamstring tendons, namely semitendinosus and gracilis, by securing the looped tendons to the femur and tibia in order to repair damaged anterior and posterior cruciate ligaments.
Relief of pain and restoration of knee finction arising from damage to anterior of posterior cruciate ligaments.
Product codes
HMC
Device Description
A Ligament Anchor system comprising a range of Ligament Anchors, Ligament Staples (Claws) and Bone Screws.
The devices are used in conjunction with the patient's medial hamstring tendons, namely semitendinosus and gracilis. by securing the looped tendons to the femur and tubia in order to repair damaged anterior and posterior cruciate ligaments.
A dedicated Ligament Claw Impactor is used during unpaction of the Ligament Claw into the patient's femur.
Each of the implantable devices is manufactured from titanium which is certified to BS 7252 Part 3 (ISO 5832 Part 3)
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
femur and tubia
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
This submission is supported by mcchanical test data and clinical results confirming the device's safety and effectiveness. The device has been in clinical use outside the USA for approximately four years and no significant post-operative problems have been reported.
Key Metrics
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Predicate Device(s)
The (Linvated) Concept 6.5mm Screw and Spiked Washer Anchoring Implant
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.
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