(59 days)
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No
The device description focuses on the mechanical components of an intramedullary nail system and does not mention any software, algorithms, or capabilities related to AI or ML.
Yes
The device is described as an intramedullary nail system (Synthes PFN System) intended to treat various proximal femoral fractures by stabilizing them. Stabilizing fractures is a therapeutic action aimed at restoring function and healing.
No
The device description indicates it is an intramedullary nail used for treating fractures, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components made of titanium alloy and stainless steel, such as intramedullary nails, screws, pins, and bolts. This indicates a hardware-based medical device, not a software-only one.
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 for diagnosis, monitoring, or screening.
- Synthes PFN System Function: The description clearly states the Synthes PFN System is an intramedullary nail used to treat bone fractures. It is an implantable device used directly within the body for structural support and stabilization.
The device's intended use and description are entirely focused on surgical treatment of bone fractures, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
The Synthes PFN System is intended to treat stable and unstable proximal fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures.
Product codes
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Device Description
Synthes PFN System is an intramedullary nail which utilizes a weightbearing dynamic femoral neck screw and an anti-rotational parallel hip pin. Distal interlocking is performed with an aiming arm and can be either static or dynamic. The following components makeup the PFN system: proximal femoral nails, hip pins, femoral neck screws, 4.9 mm locking bolts, and 17 mm end caps.
The PFN has a 17 mm proximal diameter, and is 240 mm in length. The PFN features an angle between femoral neck / shaft ranging from 125° - 140°. It has two proximal holes: one is 6.5 mm in diameter and the other is 11 mm in diameter. Two distal holes accept the 4.9 mm locking bolts. The hip pin, femoral neck screws, and 4.9 mm locking bolts are used to lock the PFN into place. The hip pin is 6.5 mm in diameter and is available in lengths ranging from 75 mm to 120 mm. The femoral neck screw is 11 mm in diameter and is available in lengths ranging from 80 mm to 120 mm. The 4.9 mm locking bolts have a 4.9 mm diameter and are available in lengths ranging from 26 mm to 100 mm. The proximal end of the PFN accepts a 17 mm end cap. The end cap is 17 mm in diameter and is available in 0 to 15 mm extensions. Synthes PFN System is manufactured from a titanium alloy and 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
proximal 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
Based on the mechanical test results, the PFN is at least equivalent to the GLN.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 all capital letters. To the left of the word is a circular logo. A small circled R is located to the right of the word.
Attachment IX:
97009 Summary of Safety and Effectiveness Information
[510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli. PA 19301
(610) 647-9700 Contact: Sheri Musgnung January 1997
MAR 1 3 1997
Synthes Proximal Femoral Nail (PFN) is compared to Howmedica's Gamma Locking Nail (GLN).
The Synthes PFN System is intended to treat stable and unstable proximal fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures.
Howmedica's GLN is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, and high subtrochanteric fractures (without distal extensions).
Synthes PFN System is an intramedullary nail which utilizes a weightbearing dynamic femoral neck screw and an anti-rotational parallel hip pin. Distal interlocking is performed with an aiming arm and can be either static or dynamic. The following components makeup the PFN system: proximal femoral nails, hip pins, femoral neck screws, 4.9 mm locking bolts, and 17 mm end caps.
The PFN has a 17 mm proximal diameter, and is 240 mm in length. The PFN features an angle between femoral neck / shaft ranging from 125° - 140°. It has two proximal holes: one is 6.5 mm in diameter and the other is 11 mm in diameter. Two distal holes accept the 4.9 mm locking bolts. The hip pin, femoral neck screws, and 4.9 mm locking bolts are used to lock the PFN into place. The hip pin is 6.5 mm in diameter and is available in lengths ranging from 75 mm to 120 mm. The femoral neck screw is 11 mm in diameter and is available in lengths ranging from 80 mm to 120 mm. The 4.9 mm locking bolts have a 4.9 mm diameter and are available in lengths ranging from 26 mm to 100 mm. The proximal end of the PFN accepts a 17 mm end cap. The end cap is 17 mm in diameter and is available in 0 to 15 mm extensions. Synthes PFN System is manufactured from a titanium alloy and stainless steel.
Based on the mechanical test results, the PFN is at least equivalent to the GLN.