(61 days)
Not Found
Not Found.
No
The device description and intended use clearly describe simple, non-electronic surgical pins and wires made of stainless steel, with no mention of software, data processing, or any technology that could incorporate AI/ML.
Yes
The device is used for "fixation of bone fractures" and "bone reconstructions," which are therapeutic interventions.
No.
The device description indicates that Kirschner Wires and Steinmann Pins are used for fixation of bone fractures, bone reconstructions, and as guide pins for other implantations, which are all therapeutic or interventional uses, not diagnostic ones.
No
The device description clearly states it consists of physical components (Kirschner wires and Steinmann pins) made of stainless steel, which are hardware.
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.
- Device Description and Intended Use: The description clearly states that the Kirschner Wires and Steinmann Pins are used for fixation of bone fractures, bone reconstructions, and as guide pins for skeletal traction. These are all procedures performed on the body, not with specimens taken from the body.
The device is a surgical implant/instrument used directly in the treatment of bone conditions.
N/A
Not Found. This is not an FDA summary for a SaMD/AI/ML 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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|-------------------------------------------------------------------|
| 510(K) CONTACT: | Cheryl Hastings
Manager, Pre-clinical Device Evaluation |
| TRADE NAME: | Sterile Kirschner Wires and Steinmann Pins |
| COMMON NAME: | Bone Fixation Fasteners |
| CLASSIFICATION: | 888.3040 Smooth or threaded bone fixation fasteners |
| DEVICE PRODUCT CODE: | 87 HTY and 87 JDW |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | DePuy Non-sterile Kirschner Wires and Steinmann Pins |
INTENDED USE AND DEVICE DESCRIPTION:
The Sterile Kirschner Wires and Steinmann Pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implantation through the skin so that traction may be applied to the skeletal system.
This system consists of sterile, smooth and threaded Kirschner wires (K-wires) and Steinmann pins ranging in length from 4 to 9 inches and ranging in diameter from 0.028 to 0.188 inches. All of the K-wires and Steinmann pins except the 6" K-wires are available with four point style options: trocar, bayonet, double end trocar and double end bayonet. The 6" K-wires are available with double end trocar points. All of the K-wires and Steinmann pins are manufactured from 316 LVM stainless steel.
BASIS OF SUBSTANTIAL EQUIVALENCE:
A comparison of the sterile K-wires and Steinmann pins described in this submission and the non-sterile devices sold prior to 1976 shows that they are very similar or identical in terms of design, sizes, material and intended use. The only significant difference between the two systems is that the system described in this submission is provided sterile while the system sold by DePuy prior to 1976 was non-sterile.