(144 days)
I'm sorry, I cannot provide an answer as the input "Not Found" does not contain the necessary information to identify the K/DEN numbers.
The input "Not Found" does not contain any K/DEN numbers. Therefore, I cannot identify any reference devices.
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an implant system designed to secure screws to bone plates, not to treat or cure a disease or condition. It is a mechanical aid for fixation in trauma, tumor, or infection cases.
No
Explanation: The device is an implant system (nut, washer, temporary holding screw) designed to secure screws to plates in bone, specifically for osteoporotic bone in cases of trauma, tumor, or infection. Its purpose is mechanical fixation, not diagnosis. The "Intended Use" section clearly describes its function in surgical procedures, unrelated to detecting or identifying medical conditions.
No
The device description clearly outlines physical components (nut, washer, temporary holding screw) made of materials like titanium or stainless steel, indicating it is a hardware-based implant system.
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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- Schuhli Implant System Function: The Schuhli Implant System is a surgical implant designed to be used within the human body to secure bone plates and screws. It is a mechanical device used for orthopedic fixation.
- Lack of Specimen Analysis: The description of the Schuhli Implant System does not involve the analysis of any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Schuhli Implant System clearly falls outside the definition and function of an In Vitro Diagnostic device.
N/A
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Attachment 3: Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301
Contact Name: Angela Silvestri (610) 647-9700 October 27, 1995
Device Name: Synthes Schuhli Implant System is compared to Synthes Dynamic Compression Plates and screws.
The Schuhli Implant System is intended for use with Synthes long bone and small bone plates and screws. The Schuhli Assembly locks the screw to the plate (independent of bone contact) and has the potential to decrease the possibility of the screw loosening and backing out of the bone. The devices are designed for, but are not limited to, use in osteoporotic bone for unicorical (of the far cortex) or bicorical fixation in cases of trauma, tumor, or infection, and as fixed angle devices (where the angle between two supporting members is fixed).
The Schuhli Implant System consists of a nut, a washer, and a temporary holding screw. The nut fits into the underside of the plate and has spikes which secure the nut to bone. The temporary holding screw is used to hold the Schuhli to the plate (before the screws are placed) while the surgeon obtains the correct placement of the plate. The washer fits into the plate's screw hole, accepting the head of a screw. The Schuhli Implant System is available in two sizes (4.5 mm and 3.5 mm); each size is available in either titanium or stainless steel, and is used with either titanium or stainless steel compression plates and screws, respectively.
WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Synthes Schuhli Implant System will be provided to the user sterile. Gamma radiation will be used to sterilize the device.
Based on mechanical test results, the Schuhli Implant System is substantially equivalent to Synthes Dynamic Compression Plates and screws.