(336 days)
Not Found
No
The document describes a mechanical interference screw for bone graft fixation and does not mention any AI or ML components.
No
The device is described as an interference screw intended to provide bone-tendon-bone patellar graft fixation, which is a surgical implant rather than a therapeutic device that delivers therapeutic treatment or diagnosis.
No
The device is an interference screw used for bone-tendon-bone graft fixation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical, absorbable interference fixation screw made of PLLA, available in various sizes and lengths, and designed for surgical implantation. This is a hardware device, not software.
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 for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (an interference screw) used to fix bone-tendon-bone grafts during surgery. It is a physical device inserted into the body.
- Intended Use: The intended use is to provide mechanical fixation of a graft within a surgical procedure, not to analyze biological samples.
The information about imaging modalities (x-rays, MRI, CAT scans) is relevant because the screw's visibility on these scans is a characteristic of the implant itself, not an indication that the device is used for diagnostic imaging of the body.
N/A
Intended Use / Indications for Use
The Phantom PLLA Interference Screw is an absorbable interference fixation screw.
Product codes
87 HWC
Device Description
The Phantom PLLA Interference Screw is an absorbable interference fixation screw. The DePuy DuPont Phantom™ Interference Screw is a fully threaded cancellous bone screw available in 7.0mm, 8.0mm and 9.0mm diameter sizes. Each diameter is available in either 15, 20, 25, and 30mm lengths and is offered in cannulated and non-cannulated versions.
The tip of the 9mm sized screw is tapered to a point which produces the self tapping feature of the screw. The screw is inserted by a square drive which is broached into the minor diameter of the screw body. The headless, low profile design minimizes subcutaneous surface protrusions. The threads are a symmetrical thread form designed to equally match stiffness between bone and thread. The Phantom screw is radiolucent on x-rays, but can be visualized with MRI and CAT scans.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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
NOV 1 8 1996
X. SUMMARY OF SAFETY AND EFFECTIVENESS
SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary
| NAME OF FIRM: | DePuy Inc
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|-----------------|----------------------------------------------------------------------------------|
| FIRM CONTACT: | Steve Wentworth
Regulatory Affairs Manager
Tel. No. (219) 372-7171 |
| TRADE NAME: | Phantom™ PLLA Interference Screw |
| COMMON NAME: | Bone/Tendon/Bone Screw |
| CLASSIFICATION: | Smooth or threaded bone fixation fastener: 888.304- |
DEVICE PRODUCT CODE: 87 HWC
SUBSTANTIALLY EQUIVALENT DEVICES:
- BioScrew® Fixation System (Linvatec) - K933719
- M. Kurosaka Interference Screw (DePuy) - K933798
- Biologically Quiet Interference Screw (Instrument Makar) - K943249
DEVICE DESCRIPTION AND INTENDED USE:
The Phantom PLLA Interference Screw is an absorbable interference fixation screw. The DePuy DuPont Phantom™ Interference Screw is a fully threaded cancellous bone screw available in 7.0mm, 8.0mm and 9.0mm diameter sizes. Each diameter is available in either 15, 20, 25, and 30mm lengths and is offered in cannulated and non-cannulated versions.
The tip of the 9mm sized screw is tapered to a point which produces the self tapping feature of the screw. The screw is inserted by a square drive which is broached into the minor diameter of the screw body. The headless, low profile design minimizes subcutaneous surface protrusions. The threads are a symmetrical thread form designed to equally match stiffness between bone and thread. The Phantom screw is radiolucent on x-rays, but can be visualized with MRI and CAT scans.
1
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Phantom™ Interference Screw, M. Kurosaka Interference Screw and the BioScrew® are intended to provide bone-tendon-bone patellar graft fixation, employing the same principles of graft fixation. These fixation screws provide an interference fit engaging both the drill tunnel and the bone plug of the graft. The Phantom™ Interference Screw is substantially equivalent to the M. Kurosaka Screw with respect to design and intended use and is substantially equivalent in material, design and intended use to the Bioscrew.
Both the Phantom™ Interference Screw and the Bioscrew® are manufactured from PLLA (Poly L-Lactic Acid) absorbable polymers and the M. Kurosaka/Advantage Screw is manufactured from Ti-6A1-4V alloy. All three screws are headless and fully threaded. The BioScrew® is offered in a cannulated version only. The M. Kurosaka Interference Screw and the Phantom™ Interference Screw are offered in both cannulated and non-cannulated versions.
Reg\510\1996\phantom.new