(86 days)
Not Found.
Not Found.
No
The 510(k) summary describes a mechanical orthopedic screw and does not mention any software, algorithms, or AI/ML related terms or functionalities.
Yes
The device is described as being "intended for fracture fixation of long bones and long bone fragments," which is a therapeutic intervention to treat a medical condition.
No
Explanation: The device is a surgical implant (screws for fracture fixation), not a device used to identify or diagnose a medical condition.
No
The device description clearly states it is a physical implant (screws) made of stainless steel or Ti Alloy, intended for fracture fixation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fracture fixation of long bones and long bone fragments." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical screw designed to be implanted into bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not interact with or analyze any biological specimens.
The information provided clearly describes a surgical implant, not a diagnostic test performed in vitro.
N/A
Not Found. This is not an FDA summary for a SaMD device.
§ 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
NOV - 8 1996
Attachment B: Summary of Safety and Effectiveness Information
Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
(610) 647 - 9700 Contact: Angela J. Silvestri August 1996
Synthes Sterile 4.5 mm Cannulated Screws are compared to Synthes 4.0 mm Cancellous Screws.
Synthes 4,5 mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments. Synthes 4.5 mm Cannulated Screws are available in various thread length configurations (partially or fully threaded). The 4.5 mm Cannulated Screw features self-drilling/self-tapping flutes and cancellous threads for use in cancellous bone. The screws are used in conjunction with a guide wire for precise placement in bone. Synthes 4.5 mm Cannulated Screws are manufactured from stainless steel or Ti Alloy.
Synthes 4.5 mm Cannulated Screws will be provided sterile, gamma radiation will be used to sterilize the device.
Based on mechanical testing, Synthes 4.5 mm Cannulated Screws are at least equivalent to Synthes 4.0 mm Cancellous Screws.