SYNTHES STERILE 4.5 MM CANNULATED SCREWS
Device Facts
| Record ID | K963172 |
|---|---|
| Device Name | SYNTHES STERILE 4.5 MM CANNULATED SCREWS |
| Applicant | Synthes (Usa) |
| Product Code | HWC · Orthopedic |
| Decision Date | Nov 8, 1996 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Synthes 4.5 mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.
Device Story
Device: 4.5 mm cannulated screws; stainless steel or Ti alloy construction. Input: guide wire for precise placement. Operation: self-drilling/self-tapping flutes; cancellous threads. Output: mechanical fixation of long bone fractures. Usage: clinical setting; orthopedic surgeon. Benefit: precise placement via guide wire; stabilization of bone fragments.
Clinical Evidence
Bench testing only; mechanical testing performed to demonstrate equivalence to predicate.
Technological Characteristics
Materials: stainless steel or Ti alloy. Features: 4.5 mm diameter, cannulated design, self-drilling/self-tapping flutes, cancellous threads. Sterilization: gamma radiation.
Indications for Use
Indicated for fracture fixation of long bones and long bone fragments in patients requiring internal fixation of cancellous bone.
Regulatory Classification
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.
Predicate Devices
- Synthes 4.0 mm Cancellous Screws
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