(118 days)
DePuy M. Kurosaka Interference Screws
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No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities, let alone AI/ML.
No.
The device is an interference screw used for fixation and stability of bone grafts in ACL reconstruction. It is an orthopedic implant, not a device that provides therapy itself.
No
Explanation: The device is an interference screw used for fixation and stability in ACL reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical, titanium alloy bone screw, which is a hardware component.
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 includes tests for diagnosis, monitoring, screening, and prognosis.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a screw) used to fix bone in a specific surgical procedure (ACL reconstruction). It is a physical device inserted into the body, not a test performed on a sample outside the body.
The device's function is mechanical fixation within the body, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Advantage Magnum Interference Screws are intended to provide early rigid fixation and stability of the bone block in bone/ patellar tendon/ bone graft surgical procedures for Anterior Cruciate Ligament (ACL) reconstruction. They are specifically intended for use in bone tunnels 3 which have been enlarged due to tunnel/graft mismatch or revision of a prior ACL reconstruction.
Product codes
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Device Description
The Advantage Magnum Screw is a fully threaded, cannulated, Titanium alloy, cancellous bone screw, available in diameters of 11, 13 and 15mm and in lengths of 15, 20, 25 and 30mm. The tip of the screw is tapered to a point which produces the self-tapping feature of the screw. The screw is inserted by a hex drive which is broached into the minor diameter of the screw itself which minimizes the size of the head of the screw. The headless, low profile design minimizes subcutaneous surface protrusions. The large cancellous threads are a symmetrical thread form with a smooth radius at the base of the threads.
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
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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
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Key Metrics
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Predicate Device(s)
DePuy M. Kurosaka Interference Screws
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
SUMMARY OF SAFETY AND EFFECTIVENESS
JUN - 6 1996
| NAME OF FIRM: | DePuy Inc. |
|---|---|
| P.O. Box 988 | |
| Warsaw, IN 46581-0988 | |
| 510(k) CONTACT: | Cheryl Hastings |
| Manager of Pre-clinical Device Evaluation | |
| TRADE NAME: | Advantage Magnum Interference Screws |
| CLASSIFICATION NAME: | Smooth or threaded metallic bone fixation fastener |
| COMMON NAME: | Bone/tendon/bone interference fixation screw |
| SUBSTANTIALLY EQUIVALENT DEVICE: | DePuy M. Kurosaka Interference Screws |
DEVICE DESCRIPTION:
The Advantage Magnum Screw is a fully threaded, cannulated, Titanium alloy, cancellous bone screw, available in diameters of 11, 13 and 15mm and in lengths of 15, 20, 25 and 30mm. The tip of the screw is tapered to a point which produces the self-tapping feature of the screw. The screw is inserted by a hex drive which is broached into the minor diameter of the screw itself which minimizes the size of the head of the screw. The headless, low profile design minimizes subcutaneous surface protrusions. The large cancellous threads are a symmetrical thread form with a smooth radius at the base of the threads.
INTENDED USE:
The Advantage Magnum Interference Screws are intended to provide early rigid fixation and stability of the bone block in bone/ patellar tendon/ bone graft surgical procedures for Anterior Cruciate Ligament (ACL) reconstruction. They are specifically intended for use in bone tunnels 3 which have been enlarged due to tunnel/graft mismatch or revision of a prior ACL reconstruction.
SUBSTANTIAL EQUIVALENCE:
The Advantage Magnum Interference Screws are manufactured from the same material and have the same intended use as the DePuy M. Kurosaka Interference Screws. The only significant difference between the two designs is that the Advantage Magnum Interference Screws have larger diameters and are available in a shorter length than the M. Kurosaka Screws. Due to their increased diameter, the mechanical performance of the Advantage Magnum Screws is expected to be equal to or better than that of the M. Kurosaka Screws.