(82 days)
Depuy M. Kurosaka™ Interference Screw
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No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or related concepts in the provided text.
Yes
Explanation: The device is described as a fixation screw system used in anterior cruciate ligament (ACL) reconstruction to provide interference fixation of patellar bone-tendon-bone grafts, which directly aims to treat and restore function to a damaged anatomical site.
No
The device description and intended use indicate that the DePuy Advantage Fixation Screw System is a surgical implant designed for fixation in ACL reconstruction, not for diagnostic purposes.
No
The device description clearly states it is a fully threaded titanium alloy cancellous bone screw, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The DePuy Advantage Fixation Screw System is a surgical implant designed to physically fix a bone-tendon-bone graft during ACL reconstruction surgery. It is a physical device used within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction." This is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the DePuy Advantage Fixation Screw System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Advantage Fixation Screw System is intended to be used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
Product codes
87 HWC
Device Description
The DePuy Advantage Fixation screw is a fully threaded titanium alloy cancellous bone screw available in 7mm and 9mm diameters. Each diameter is available in six (6) lengths (15, 20, 25, 30, 35, and 40mm) in a cannulated version, and in five (5) lengths (20, 25, and 40mm) in a non-cannulated version. The Advantage screw has a polished satin finish, a 29 degree included angle tapered tip, a round body thread, and a radius on the socket end of the screw. Each screw has an internal hex fitting for instrument insertion during surgery.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Depuy M. Kurosaka™ Interference Screw
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
JUN 19 1996 SUMMAI EFFECTIVENESS
Image /page/0/Picture/1 description: The image shows a document exhibit label. The word "EXHIBIT" is printed in large, bold, black letters at the top of the label. Below the word "EXHIBIT" is the roman numeral "II". There is a horizontal line between the word "EXHIBIT" and the roman numeral.
| NAME OF FIRM: | DePuy Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|----------------------|-----------------------------------------------------------------------------------|
| FIRM CONTACT: | Sally Foust
Clinical Research Specialist |
| TRADE NAME: | DePuy Advantage™ Fixation Screw System |
| COMMON NAME: | Bone Screw |
| CLASSIFICATION: | 888.3040 Smooth or threaded metallic bone fixation fastener |
| DEVICE PRODUCT CODE: | 87 HWC |
SUBSTANTIALLY EQUIVALENT DEVICES:
Depuy M. Kurosaka™ Interference Screw DePuy M. Kurosaka™ Fixation Screw Arthrex TranstibialTM System
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy Advantage Fixation screw is a fully threaded titanium alloy cancellous bone screw available in 7mm and 9mm diameters. Each diameter is available in six (6) lengths (15, 20, 25, 30, 35, and 40mm) in a cannulated version, and in five (5) lengths (20, 25, and 40mm) in a non-cannulated version. The Advantage screw has a polished satin finish, a 29 degree included angle tapered tip, a round body thread, and a radius on the socket end of the screw. Each screw has an internal hex fitting for instrument insertion during surgery.
The DePuy Advantage Fixation Screw System is intended to be used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Advantage Fixation Screw System screws are substantially equivalent to the DePuy M. Kurosaka Interference Screws cleared for fixation of bone-tendon-bone grafts in ACL reconstruction. All of the DePuy Advantage screws and the M. Kurosaka Interference screws are manufactured from Ti-6A1-4V alloy. All are available in 7mm and 9mm diameters in numerous lengths in cannulated and non-cannulated versions.