(75 days)
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No
The description focuses on the mechanical components of a plate and screw system for bone fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is a plate and screw system intended for mandible trauma and reconstruction, which are structural and fixation procedures, not therapeutic in nature.
No
Explanation: The device description states it is a "plate and screw system" intended for "mandible trauma and reconstruction procedures," which are treatment interventions, not diagnostic activities. It does not mention any function related to identifying, detecting, or monitoring medical conditions.
No
The device description clearly states it is a "plate and screw system" and includes physical components like plates, screws, drill guides, and insert screws, which are hardware.
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 provided description clearly states that the Synthes 2.4 mm ULPS is a "plate and screw system" intended for "mandible trauma and reconstruction procedures." This is a surgical implant used directly on the bone within the body.
- Intended Use: The intended use is for surgical procedures to repair or reconstruct the mandible, not for analyzing biological samples.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures.
The plates attach to bone via self-tapping cortex and/or locking screws, and are available in various shapes and sizes. The plates feature compression screw holes that are internally threaded to accept the 2.4 mm - 3.0 mm locking screws.
The following instrumentation is used with the 2.4 mm ULPS:
Threaded Drill Guide is used for guiding the drill bit to bone by threading the tip into the plate's screw hole. The bore (inside diameter) of the drill guide is dependent upon the screw size when selected since each screw diameter requires a specific drill diameter. They are available with bores from 1.5 mm to 2.5 mm.
2.4 mm Insert Screw is used by the surgeon while bending the plate to avoid deforming the threaded screw holes. The inserts are screwed into the plate holes prior to bending and removed once the bending operation is complete.
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
mandible
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)
mechanical test results, we believe that the devices are at least equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters, with a circled "R" symbol to the left of the word. To the right of the word "SYNTHES" is the number "K96147" written in black ink. The number appears to be handwritten.
Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (USA) 1690 Russell Road Paoli, PA 19301
JUN 26 1996
(610) 647-9700 Contact: Angela Silvestri April 1996
Device: Synthes 2.4 mm Universal Locking Plate System, as compared to Synthes 2.7 mm Reconstruction Plate System.
The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures.
The plates attach to bone via self-tapping cortex and/or locking screws, and are available in various shapes and sizes. The plates feature compression screw holes that are internally threaded to accept the 2.4 mm - 3.0 mm locking screws.
The following instrumentation is used with the 2.4 mm ULPS:
Threaded Drill Guide is used for guiding the drill bit to bone by threading the tip into the plate's screw hole. The bore (inside diameter) of the drill guide is dependent upon the screw size when selected since each screw diameter requires a specific drill diameter. They are available with bores from 1.5 mm to 2.5 mm.
2.4 mm Insert Screw is used by the surgeon while bending the plate to avoid deforming the threaded screw holes. The inserts are screwed into the plate holes prior to bending and removed once the bending operation is complete.
Synthes will provide the device non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended using the Association for the Advancement of Medical Instrumentation (AAMI) guideline "Good Hospital Practice: Steam Sterilization and Sterility Assurance."
Based on mechanical test results, we believe that the devices are at least equivalent.