(33 days)
Richard's IMSC Five Nail, Ace's Retrograde Trauma Nail
Not Found
No
The device description and intended use clearly describe a mechanical intramedullary fixation device and its components, with no mention of software, algorithms, or any features suggestive of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is an intramedullary fixation device intended to stabilize fractures, which is a structural support rather than a device that delivers therapy.
No
This device is an intramedullary fixation system intended to stabilize fractures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium alloy (nails, screws, bolts, end caps) used for fracture fixation, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for stabilizing fractures of the distal femur. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a cannulated and solid locking intramedullary fixation device made of titanium alloy, including nails, screws, bolts, and end caps. These are all components used for internal fixation of bones.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The Synthes Ti DFN System is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Synthes Ti DFN System is generally intended to stabilize fractures of the distal femur. Specifically, the Ti DFN is intended for supracondylar fractures (including those with intraarticular and/or extra-articular involvement), pathologic fractures, mal-unions, non-unions, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures proximal to a total knee, fractures distal to a total hip, fractures in the multiply injured patient, fractures in the morbidly obese patient, and fractures in osteoporotic bone. The Ti DFN can be used in either reamed or non-reamed applications.
Product codes
Not Found
Device Description
Synthes Ti DFN System is a cannulated and solid locking intramedullary fixation device. The following components make up the DFN system: Transverse Locking Nails, 6.0 mm Ti Locking Screws, 4.9 mm Ti Locking Bolts, and Ti End Caps. Synthes Ti DFN System is manufactured from a titanium alloy.
Synthes Ti DFN has various locking options both proximally and distally. The Ti DFN are available in diameters ranging from 9 mm to 13 mm, and lengths ranging from 160 - 460 mm. The 6.0 mm Ti Locking Screws and 4.9 mm Ti Locking Bolts are used to lock the DFN into place. The Ti End Cap locks the distal 6.0 mm Ti Locking Screw to the Ti DFN.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Richard's IMSC Five Nail, Ace's Retrograde Trauma Nail
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(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 registered trademark symbol is located to the right of the word.
KA70733
Attachment IX:
Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Sheri Musgnung February 1997
Synthes Ti Distal Femoral Nail (DFN) is compared to Richard's IMSC Five Nail and Ace's Retrograde Trauma Nail.
APR - 2 1997
The Synthes Ti DFN System is generally intended to stabilize fractures of the distal femur. Specifically, the Ti DFN is intended for supracondylar fractures (including those with intraarticular and/or extra-articular involvement), pathologic fractures, mal-unions, non-unions, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures proximal to a total knee, fractures distal to a total hip, fractures in the multiply injured patient, fractures in the morbidly obese patient, and fractures in osteoporotic bone. The Ti DFN can be used in either reamed or non-reamed applications.
Richard's IMSC Five Nail is intended to stabilize fractures of the distal femur including supracondylar fractures of the distal femur, including those which extend into the articular surface, pathologic fractures of the distal femur, mal-unions of the distal femur, failed distal femoral osteosynthesis, and distal femur fractures in osteoporotic bone.
Ace's Retrograde Trauma Nail is intended to stabilize fractures of the distal femur including supracondylar fractures of the distal femur, including those with extra-articular comminution and/or intra-articular movement, malunions, osteoporosis, osteotomies of the distal femur, failed osteosyntheses of the distal femur, fractures proximal to a total knee, and obese or multiple trauma patients with femoral shaft fractures.
Synthes Ti DFN System is a cannulated and solid locking intramedullary fixation device. The following components make up the DFN system: Transverse Locking Nails, 6.0 mm Ti Locking Screws, 4.9 mm Ti Locking Bolts, and Ti End Caps. Synthes Ti DFN System is manufactured from a titanium alloy.
Synthes Ti DFN has various locking options both proximally and distally. The Ti DFN are available in diameters ranging from 9 mm to 13 mm, and lengths ranging from 160 - 460 mm. The 6.0 mm Ti Locking Screws and 4.9 mm Ti Locking Bolts are used to lock the DFN into place. The Ti End Cap locks the distal 6.0 mm Ti Locking Screw to the Ti DFN.
Based on the information contained in this 510(k), the Ti DFN is at least equivalent to the Richard's IMSC Five Nail and Ace's Retrograde Trauma Nail.
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