(71 days)
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No
The summary describes a mechanical implant (femoral nails and screws) and its intended use for fracture fixation. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The performance studies focus on mechanical testing.
No.
The device is an orthopedic implant for stabilizing fractures, not a therapeutic device that delivers therapy or has a therapeutic effect on a disease/condition beyond mechanical support.
No
Explanation: The device, the TriMax Nail System, is an intramedullary nail system designed to fix bone fractures. Its purpose is to provide mechanical support for fracture healing, not to diagnose medical conditions or diseases.
No
The device description explicitly states that the TriMax Nail System includes femoral nails and screws, which are physical hardware components made of stainless steel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implantable system (femoral nails and screws) used for the surgical fixation of bone fractures and other conditions of the femur. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a system of femoral nails and screws made from stainless steel, which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
Femoral/recon antegrade nails and retrograde nails are indicated for shaft fractures including severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; bone lengthening shortening femur reconstruction following turnor resection and grafting. fractures in osteoporotic bone: severely comminuted shaft fractures, pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed supracondylar fractures; and prophylactic nailing of impending pathologic fractures.
Additional indications for the femoral/recon antegrade include: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures.
Additional indications for retrograde nails include: severely comminuted supracondylar fractures with or without difficult intra-articular extension, fractures that require opening the knee joint to stabilize the femoral condylar segment. Also, fractures above total knee implants.
The TriMax Nail System is intended to be removed upon fracture healing.
Product codes
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Device Description
The TriMax Nail System includes femoral nails and screws. All components are manufactured from 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
Femoral
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
Mechanical testing was performed on the system and all of the test results indicate that the TriMax Nail System is capable of withstanding normal in vivo loading without failure.
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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§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
.. D . 2 . 2 = 5 .. - 3
Summary of Safety and Effectiveness TriMax Nail System
Substantial Equivalence Information
The TriMax Nail System is similar to the following systems:
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- ZMS Intramedullary Fixation System (Zimmer)
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- Grosse & Kempf Locking Nail (Howmedica)
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- Retrograde Femoral Nail (Biomet)
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- Aim Titanium Supracondylar Nail (Ace)
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- Alta Nail (Howmedica)
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- Femoral Nail System (Synthes)
All of the devices listed above are similar in design to the TriMax Nail System. The safety and effectiveness of the TriMax Nail System is based on the long history of use of these devices in the market place.
Device Description
The TriMax Nail System includes femoral nails and screws. All components are manufactured from stainless steel.
Indications for Use
Femoral/recon antegrade nails and retrograde nails are indicated for shaft fractures including severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; bone lengthening shortening femur reconstruction following turnor resection and grafting. fractures in osteoporotic bone: severely comminuted shaft fractures, pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed supracondylar fractures; and prophylactic nailing of impending pathologic fractures.
Additional indications for the femoral/recon antegrade include: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures.
Additional indications for retrograde nails include: severely comminuted supracondylar fractures with or without difficult intra-articular extension, fractures that require opening the knee joint to stabilize the femoral condylar segment. Also, fractures above total knee implants.
The TriMax Nail System is intended to be removed upon fracture healing.
Mechanical Testing
Mechanical testing was performed on the system and all of the test results indicate that the TriMax Nail System is capable of withstanding normal in vivo loading without failure.
DEC 2 7 1996