(42 days)
The Knowles Pin is provided non-sterile. The device may be used for bone reconstruction, for reducible intracapsular fracture of the femoral neck and to moderate slipped upper femoral epiphyses.
The Knowles Pin is partially threaded wires machined with a trocar point. The threads engage in cancellous and subchondral bone of the femoral head. The distal portion of the pin is broken off at the scored line following fracture fixation. The Knowles Pin is divided two kinds of styles: square and hexagonal collar. The standard Knowles Pin is a hexagonal collar, a thread length ranges from 1.25 inches (32 mm) to 3 inches (76 mm), and a thread diameter of 4.0 and 4.8 mm. Another pin has a square collar, both a thread length and thread diameter is the same as hexagonal collar.
This document is a 510(k) summary for a medical device called the "Syntec-Taichung Non-sterile Knowles Pin," used for bone fixation. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The provided text focuses on:
- Device Description: Material, styles (square and hexagonal collar), dimensions.
- Indication for Use: Bone reconstruction, reducible intracapsular femoral neck fractures, and moderate slipped upper femoral epiphyses.
- Regulatory Information: Classification as Class II, product code JDW, and the FDA's clearance of the 510(k) submission.
There is no mention of any performance metrics, studies, or acceptance criteria within the provided text. Therefore, I cannot generate the requested table or answer questions related to study design, sample sizes, ground truth, or expert involvement. The document primarily serves as a regulatory clearance document rather than a performance evaluation report.
§ 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.