(211 days)
Not Found
Not Found
No
The description details a mechanical plate and screw system made of titanium, with no mention of software, algorithms, or any terms related to AI/ML.
No.
The device is a plate and screw system for fracture fixation and reconstructive procedures, not a device used for treating diseases or improving health outcomes in a therapeutic sense, but rather a structural support.
No
The device is a plate and screw system ("Synthes Midfacial System") used for surgical fixation in the midface and craniofacial skeleton, not for diagnosing conditions.
No
The device description explicitly states it is a "plate and screw system, manufactured from commercially pure (CP) 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Synthes Midfacial System is a plate and screw system made of titanium, intended for surgical implantation to fix bones in the midface and craniofacial skeleton.
- Intended Use: The intended use is for surgical procedures to treat trauma, perform reconstructive surgery, and selective orthognathic surgery. This involves direct intervention on the patient's body, not the analysis of specimens.
The information provided clearly describes a surgical implant device, not a device used for testing samples outside of the body.
N/A
Intended Use / Indications for Use
The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and is intended for use in selective trauma of the midface and craniofacial skeleton: craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Product codes
Not Found
Device Description
The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium. The plates are available in a variety of configurations to accommodate various fracture sites, and attach to bone via 1.3 mm or 1.7 mm self-tapping screws, with a low plate/screw profile. Synthes will provide the device non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
midface and craniofacial skeleton; maxilla and chin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on mechanical test results, the Synthes Midfacial System is equivalent to the Howmedica Luhr Pan Fixation System,.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 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. To the left of the word is a circular logo with a design inside. A small circle with an R inside is to the right of the word.
8 K953806
Attachment VI: Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri August 9, 1995
Device: Synthes Midfacial System, as compared to the Howmedica Luhr Pan Fixation System.
The Synthes Midfacial System is a plate and screw system, manufactured from commercially pure (CP) titanium, and is intended for use in selective trauma of the midface and craniofacial skeleton: craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The plates are available in a variety of configurations to accommodate various fracture sites, and attach to bone via 1.3 mm or 1.7 mm self-tapping screws, with a low plate/screw profile.
The Howmedica Luhr Pan Fixation System, manufactured from Vitallium® alloy, is also intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. The plates are also available in a variety of configurations to accommodate various fracture sites. and attach to bone via 1.3 mm or 1.5mm self-tapping screws, with a low plate/screw profile.
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 Midfacial System is equivalent to the Howmedica Luhr Pan Fixation System,.