(171 days)
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No
The device description and summary of performance studies indicate a mechanical plate and screw system, with no mention of AI or ML technology.
No
The device is a plate and screw system intended for bone fixation in various surgical procedures, not for therapeutic treatment.
No
The device description indicates it is a "plate and screw system" used for fixation in surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a "plate and screw system, manufactured from commercially pure titanium," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant system (plates and screws) used for fixing bones in the face and skull. It is used in the body during surgery, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
This device is a surgical implant/fixation system, not an IVD.
N/A
Intended Use / Indications for Use
The Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:
- Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; . reconstructive surgery; and craniofacial surgery
- ENT: trauma of the nasal bones .
- Neurosurgery: osteosynthesis of the cranial bones. .
Product codes
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Device Description
The Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium. The plates are available in a variety of shapes and sizes and attach to bone via 2.0 mm, 2.4 mm, or 2.7 mm self-tapping screws. Synthes will provide the device non-sterile.
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
Oral, maxillofacial; nasal bones; cranial bones
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
Based on mechanical test results, the Synthes Mandibular Fixation System is substantially equivalent to the W. Lorenz Würzburg Titanium Miniplate System.
Key Metrics
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Predicate Device(s)
W. Lorenz Würzburg Titanium Miniplate System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized figure inside. A small circle with a degree symbol is located to the right of the word.
Attachment VI:
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Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri September 15, 1995
Device: Synthes Mandibular Modular Fixation System, as compared to the W. Lorenz Würzburg Titanium Miniplate System.
The Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:
- Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; . reconstructive surgery; and craniofacial surgery
- ENT: trauma of the nasal bones .
- Neurosurgery: osteosynthesis of the cranial bones. .
The plates are available in a variety of shapes and sizes and attach to bone via 2.0 mm, 2.4 mm, or 2.7 mm self-tapping screws.
The W. Lorenz Würzburg Titanium Miniplate System, manufactured from titanium, and is intended for use in the following:
- Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; . reconstructive surgery; and craniofacial surgery
- ENT: trauma of the nasal bones .
- Neurosurgery: osteosynthesis of the cranial bones .
The plates are also available in a variety of shapes to accommodate various fracture types, and attach to bone via 2.0 mm or 2.3 mm self-tapping screws.
Synthes will provide the device non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended.
Based on mechanical test results, the Synthes Mandibular Fixation System is substantially equivalent to the W. Lorenz Würzburg Titanium Miniplate System.