(207 days)
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No
The device description and intended use are purely mechanical, describing a physical implant for fracture stabilization. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an accessory for fracture stabilization with plates and cerclage wire. While it aids in the surgical procedure, its primary function is mechanical support, not direct therapeutic treatment of the patient's condition.
No
The device description clearly states its purpose is for "augmenting fracture stabilization with plates" by providing a stable structure for cerclage wire fixation. This is a therapeutic, not a diagnostic, function.
No
The device description clearly states it is a physical implant manufactured from 316L stainless steel, 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 information is used for diagnosis, monitoring, or screening.
- Device Description: The Synthes Wire Mount is a physical implant made of stainless steel. It is used in vivo (within the body) to help stabilize bone fractures.
- Intended Use: The intended use clearly states it's for augmenting fracture stabilization with plates and cerclage wire. This is a surgical procedure performed directly on the patient's bone.
The description of the device and its intended use are entirely focused on a surgical implant used within the body, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
Synthes Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates when use of screws is contraindicated, as in the presence of intramedullary implants.
Synthes Cerclage Wire is a straight wire that is also intended to augment fracture stabilization with plates when use of screws is contraindicated, e.g., in the presence of intramedullary implants.
Product codes
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Device Description
The Synthes Wire Mount design is a "T" post with a hole perpendicular to the post axis, and a small triangular ridge on the bottom. Placing the post through the dynamic compression screw hole, inserting from the bone side of the plate, creates a stable structure for cerclage wire fixation. The cerclage wire is passed around the bone, through the Wire Mount hole above the outer surface of the plate, and then twisted with the opposite wire end. The device is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. Among the plates the Wire Mount (and cerclage wire) can be used with include, but are not limited, to Dynamic Hip Screw (DHS), Dynamic Condylar Screw (DCS), Condylar Buttress, Cobra Head, Hook, 4.5 mm Narrow, Broad Dynamic Compression (DCP), 90° Child and Adolescent Osteotomy, 110 - 130° Adult Osteotomy, 95° Condylar (including small stature plates) and 130° Angle Blade Plates (including small stature plates). The Wire Mount is manufactured from 316L stainless steel.
Synthes Cerclage Wire is a straight wire. It is also manufactured from 316L stainless steel.
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
Synthes Wire Mount (with cerclage wire) is at least equivalent to Synthes Cerclage Wire, based on the results of the testing of both devices.
Key Metrics
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Predicate Device(s)
Synthes Cerclage Wire.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A registered trademark symbol is located to the right of the word.
953777
Summary of Safety and Effectiveness Information Attachment VII: [510(k) Summary]
SYNTHES (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri August 11, 1995
Device: Synthes Wire Mount is compared to Synthes Cerclage Wire.
Synthes Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates when use of screws is contraindicated, as in the presence of intramedullary implants. The design is a "T" post with a hole perpendicular to the post axis, and a small triangular ridge on the bottom. Placing the post through the dynamic compression screw hole, inserting from the bone side of the plate, creates a stable structure for cerclage wire fixation. The cerclage wire is passed around the bone, through the Wire Mount hole above the outer surface of the plate, and then twisted with the opposite wire end.
The device is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. Among the plates the Wire Mount (and cerclage wire) can be used with include, but are not limited, to Dynamic Hip Screw (DHS), Dynamic Condylar Screw (DCS), Condylar Buttress, Cobra Head, Hook, 4.5 mm Narrow, Broad Dynamic Compression (DCP), 90° Child and Adolescent Osteotomy, 110 - 130° Adult Osteotomy, 95° Condylar (including small stature plates) and 130° Angle Blade Plates (including small stature plates). The Wire Mount is manufactured from 316L stainless steel.
Synthes Cerclage Wire is a straight wire that is also intended to augment fracture stabilization with plates when use of screws is contraindicated, e.g., in the presence of intramedullary implants. Among the plates the Cerclage Wire can be used with include, but are not limited to, DHS, DCS, Condylar Buttress, Cobra Head, Hook, 4.5 mm Narrow, Broad DCP, 90° Child and Adolescent Osteotomy, 110 - 130° Adult Osteotomy, 95° Condylar (including small stature plates), and 130° Angle Blade Plates (including small stature plates). It is also manufactured from 316L stainless steel,
Synthes Wire Mount (with cerclage wire) is at least equivalent to Synthes Cerclage Wire, based on the results of the testing of both devices.